QA Auditor Resume Samples

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T Johnston

Torrey

Johnston

3173 Wolff Parkways

New York

+1 (555) 201 1282

3173 Wolff Parkways

New York

Phone

p +1 (555) 201 1282

Experience Experience

Los Angeles, CA

QA Auditor

Los Angeles, CA

Dickens Group

Los Angeles, CA

QA Auditor

Performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments
Assist in the development, review, approval and distribution of global and local SOP, Work Instructions, forms and templates
Assist with the development of the project audit procedures
Provides audit reports to management
Perform in-process tests and calculate batch adjustments
Assist in providing basic regulatory training to operations personnel
Develop recommended changes in operating procedures and internal controls to correct existing and preclude future exceptions to established norms

Philadelphia, PA

Senior QA Auditor

Philadelphia, PA

Lehner, Pollich and Gibson

Philadelphia, PA

Senior QA Auditor

60% Conduct External cGMP audits as the lead auditor. This includes
Scheduling and identifying audit agenda
Lead audit teams including SMEs from functional areas to perform the audit
Lead author for generation of audit reports
20% Execute and continuously improve the following programs using a risk based approach: Supplier Quality Management Program, Raw Materials/Contract Laboratory Testing/Plasma Centers/GMP Service Providers Qualification, Audit Process
10% Work cross-functionally to continuously improve the Vendor Qualification Program. Support regulatory agency inspections and logistics
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers

present

Chicago, IL

QA Auditor / Senior QA Auditor

Chicago, IL

Rice, Lindgren and O'Keefe

present

Chicago, IL

QA Auditor / Senior QA Auditor

present

Provide input into the design and presentation of departmental performance metrics
Establish work priorities to meet targets and timelines
Identify, design, and implement process improvements
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
Provide guidance to internal and external customers on best practices for maintaining a quality program
Identify, design, and implement process and system improvements
Review and approve quality management records

Education Education

Bachelor’s Degree in Flexibility

University of California, San Diego

Bachelor’s Degree in Flexibility

Skills Skills

Detail oriented, strong organizational skills and ability to work independently
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients
Reliability and dependability essential
Strong knowledge of GLP
Strong verbal and written communication skills with attention to detail and accuracy
Proven flexibility and ability to adapt quickly to shifting priorities and workload
Proficiency in basic Microsoft Office Suite, including Excel, Word and PowerPoint
Ability to review and evaluate data / records. Good oral and written communication skills
Good planning and organizational skills with the ability to multi-task and prioritize effectively
Ability to follow detailed instructions

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Manager, Global QA Auditor Resume Examples & Samples

Perform audit of suppliers- audit activities include, defining the audit objective, defining audit requirements, scheduling audits with suppliers, condution of opening & closing meetings and performing audits as the lead and/or as co-lead auditor for: Components, Raw Material, Third Party Manufactures (TPM), Estee Lauder manufacturing sites and third-party testing laboratories
Ensure that audits are conducted according to EL policy and requirements, that every audit has a timely audit report issued, and that corrective action/preventative action (CAPA) plans are identified for every audit
Update the audit tracking database with audit schedule, audit report and audit observations. Rank suppliers according to EL risk profile
Participate in collecting and reporting quality matrix
Collaborate with members of the QA organization and other functions at ELC in continuous improvement of the audit program
Other duties as assigned may include management and processing of OTC complaints and processing new supplier audit requests
Minimum 5 years experience with auditing external suppliers
Good knowledge of applicable regulations and guidance documents, able to apply critical thinking skills to evaluate requirements
Knowledge of global cGMP standards
Working knowledge of 221 CFR210, 211, Heatlh Canada GMP's, ISO 22716, EFfCI and ICH Q7
Computer literate with good working knowledge of Microsoft products (SAP knowledge a plus)
Good communication skills (verbal and written, good organizational skills and should be detail oriented

Senior QA Auditor Resume Examples & Samples

60% Conduct External cGMP audits as the lead auditor. This includes
Scheduling and identifying audit agenda
Lead audit teams including SMEs from functional areas to perform the audit
Performing the audits using knowledge of regulatory requirements and knowledge of biopharmaceutical operations in areas including but not limited to QC, QA, Manufacturing, Materials Management, Supply Chain, Validation, and Local Operating Companies
Make decision on observations, observation categories, and acceptability of external audit outcome
Lead author for generation of audit reports
Make decision on acceptability of responses to external audit findings, and follow up actions as required
20% Execute and continuously improve the following programs using a risk based approach: Supplier Quality Management Program, Raw Materials/Contract Laboratory Testing/Plasma Centers/GMP Service Providers Qualification, Audit Process
10% Work cross-functionally to continuously improve the Vendor Qualification Program. Support regulatory agency inspections and logistics
10% Maintain detailed understanding of current US and international regulatory requirements. Maintain training status against curriculum requirement. Contribute to the establishment and operation of Quality Intelligence Program to ensure Shire maintains compliance to regulations. Support metrics on external audit performance

QA Auditor, Outbound Resume Examples & Samples

Ability to write reports and business correspondence
Must have HS diploma (or GED) with 1+ years of experience in a manufacturing or distrib facility; or equivalent combination of education and related experience
Warehouse experience preferred

Bioanalytical QA Auditor Resume Examples & Samples

Be knowledgeable with all relevant ICON SOPs, ISO 9000 requirements and with appropriate regulations and guidelines
Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented
Assist with the development of the project audit procedures
Conduct induction/orientation of new staff in ICON quality policies and procedures
Previous experience in a GXP quality assurance and/or research environment
Ability to liaise successfully with project teams
Competent computer skills
Proficiency in basic Microsoft Office Suite, including Excel, Word and PowerPoint

Associate QA Auditor Resume Examples & Samples

Conducting audits of Pharmaceutical Development Manufacturing Facility to ensure compliance with cGMPs, DEA, Corporate and Pharmaceutical Development standard operating procedures
Performs QA Room releases, line clearances, equipment releases and AQL inspections as required
Provides QA support to Manufacturing for clinical and commercial batches
Audit of executed batch records for compliance with cGMP and provide customer audit responses as required
Audit of raw materials, facility logs, release data
Interdepartmental communication for obtaining information and audit corrections
Comply with an ensure compliance of the department with Health, Safety and Environmental responsibilities
Assist with batch investigations as required
Zero to three years of experience working in the pharmaceutical industry in Quality Assurance
Understanding of FDA cGMPs and DEA regulations pertaining to Pharmaceutical Development
Good mathematics skills
Good computer skills, including in depth knowledge of Word and spread sheet software
Safety procedures associated with the department
Understand procedures related to document control, Quality Assurance and this job function
Candidate must be detailed oriented with effective oral and written communication skills, team oriented with effective interpersonal skills. Candidate must be responsive to timelines and adjust priorities as required
Candidate must have computer skills with MS Office

QA Auditor Resume Examples & Samples

Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues
May perform technical document review and other GxP practice activities in support of clinical development programs
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience
Successful completion of PPD Foundation Training
Solid experience in root cause analysis

Associate QA Auditor / QA Auditor Resume Examples & Samples

B.S. in science or a related field
Additional experience required for QA Auditor level
Candidates with PCR and Molecular Biology experience are highly preferred

QA Auditor Resume Examples & Samples

Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience
Meets competencies for QA Auditor I plus
Thorough knowledge of GxP and appropriate regional research regulations and guidelines (*detailed knowledge of ICH-GCP and appropriate clinical research regulations highly preferred)
Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management (*experience in conducting investigational site audits, inspection preparation & hosting of regulatory inspections highly preferred)

QA Auditor Resume Examples & Samples

Work under the supervision of the QA Manager and / or more senior auditor(s) to plan, conduct assigned audits, and complete written reports for each audit
Assist in follow up and consultancy with clients, PAREXEL management, and staff
Maintain knowledge of project / audit status in assigned areas and provide Senior Management with current informational reports upon request
Maintain current records / documents related to assigned areas
Develop a sound knowledge of PAREXEL policies, procedures, and guidelines, as well as current knowledge of applicable GxP requirements
Build good working relationships with internal clients, and within the QA team
Travel on assignment, as needed
Ability to interact professionally within a client oriented organization
Demonstrated ability to prioritize work and define steps needed to achieve specified project / audit outcomes
Experience with Microsoft based applications, and ability to learn internal computer systems
Ability to understand concepts quickly and apply them appropriately
Accurate and detail oriented
Ability to obtain an overview, i.e., ‘big picture’ / to combine details to understand process(es) / issue(s)
Strong time management skills, and ability to follow up on multiple tasks and projects
Ability to work independently, as necessary
High degree of flexibility
Works well in team environment
Fluent in English (read, written, spoken)
Foreign language skills would be desirable, but not essential
Min 2 years experience in regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area

QA Auditor Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which centres around our commitment to People, Clients and Performance.*
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.*
Travel (approximately 35%) domestic and/or international. *
Be knowledgeable with all relevant ICON SOPs, ISO 9000 requirements and with appropriate regulations and guidelines.*
Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.*
Perform quality system audits if required
Perform contract audits for Sponsor companies as required
Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.*
When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the project manager on all QA issues, including audit planning and review of audit results.*
Assist with the development of the project audit procedures.*
Assist in training new AQ auditors.*
Assist in training ICON staff regarding GCP, ISO 9000, role of QA, regulatory inspections, etc
Assist with business development activities (such as marketing presentations) when appropriate
Provide a benchmark of auditing competencies to inexperienced colleagues.*
Assume additional QA responsibilities as directed by the QA Manager or higher
Keep the person whom the QA Auditor reports to informed of any QA issues within the department that require attention
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Background in medicine, science and/or other relevant discipline and appropriate experience
Previous experience in Quality Assurance auditing and/or 2-3 years of proven clinical research experience
Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials
Ability to review and evaluated clinical data/records
Ability to successfully implement quality plans for specific phases of a trial
Good understanding of drug development and clinical trial process
Coaching/mentoring skills
Good planning and organizational skills

QA Auditor Resume Examples & Samples

As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our process adding value to our business and meeting client needs
Plan and conduct regular and random QA audits of the ICON quality system on a regional basis in order to evaluate the quality system against the requirement of relevant ISO standards, appropriate regulations and applicable guidelines. Perform the role of a lead auditor to assess the effectiveness of the quality system and to verify that the quality system is being implemented
Ensure that audit results and other quality information are formally and consistently recorded and reported and that corrective actions/preventive actions have been requested and are documented effectively
Review audit replies to QA. Follow up all outstanding replies and report issues to the relevant management for action
Assist with preparation, conduct and follow up of sponsor and regulatory audits and represent the QA corporate systems compliance unit. Assist with marketing presentations when appropriate
Liaise with clients and departmental managers on quality aspects including the attendance at meetings, oral presentations and audits
Diploma or above degree, major in pharmacy or clinical or bio-technology qualifications
Previous relevant experience in Quality Assurance auditing or equivalent services
Good understanding of the clinical development process and knowledgeable regarding the relevant guidelines and regulations for the conduct of clinical trials
Proficient in QA procedures and ICON SOPs and thorough knowledge of relevant ISO standards
Ability to review and evaluate various types of systems/processes
Ability to successfully implement quality plans for specific systems/processes
Ability to liaise successfully with departmental and office management
Ability and willingness to travel at least 30% of the time

QA Auditor Resume Examples & Samples

May perform technical document review and other GCP practice activities in support of clinical development programs
Thorough knowledge of GCP and appropriate regional research regulations and guidelines
Government agency experience strongly preferred

QA Auditor Resume Examples & Samples

Lead/support inspection readiness activities, including inspections of ICON and/or investigator sites
Lead CAPA management for inspection of ICON and /or investigator sites, where needed, including ensuring any Inspection CAPA commitments are tracked and followed until resolution
Lead CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up
Lead / support quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented
Ensure that CAPAs are formally recorded and reported and that corrective/preventive actions are documented and followed until resolution
Identify and track required effectiveness checks and ensure effectiveness checks are completed within the require timelines
Provide advise and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements
Lead / support critical CAPA initiatives, as needed
Support / lead effectiveness check audits, as needed
Support other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary
Travel (approximately 35%) domestic and/or international
Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials
Knowledge/ experience in hosting external audits and/or regulatory inspections
Knowledge / experience in CAPA management, including performing effective root cause analysis
Knowledge / experience in regulatory authority inspections an advantage
Knowledge / experience in medical Device (MDDR) an advantage
Ability to review and evaluate clinical data / records
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients
Detailed understanding of drug development and clinical trial process
Good planning and organizational skills with the ability to multi-task and prioritize effectively
Ability to work efficiently and independently under pressure
Ability and willingness to travel at least 35% of the time (international and domestic)

QA Auditor Resume Examples & Samples

Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements
Perform quality system audits and perform contract audits for Sponsor as required
When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the project manager on all QA issues, including audit planning and review of audit results
Assist in training new QA auditors and provide a benchmark of auditing competencies to inexperienced colleagues
Assist in training ICON staff regarding GCP, ISO 9000, role of QA regulatory inspections, etc
BS degree in the sciences or related field or local equivalent
Adequate experience as determined by QA Management may substitute for that requirement
Prior experience (a minimum of one year experience) in medicine, science or other relevant disciplines
Ability to review and evaluate data / records. Good oral and written communication skills
Additional experience in Document Management System/Data Management systems preferred but not required

GCP QA Auditor Resume Examples & Samples

Current experience in GxP audits in a pharmaceutical or CRO environment
Experience of inspections and directed audits would be an advantage
Thorough knowledge and understanding of GCP regulations and Guidelines
Proven flexibility and ability to adapt quickly to shifting priorities and workload

Principal QA Auditor Resume Examples & Samples

Leads a variety of client, internal or GxP audits and regulatory inspections
Provides GxP consultation and support to PPD project teams and external clients
Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
Identifies issues impacting the quality and/or integrity of clinical research
Programs, determines root cause of non-conformance and develops strategies to address issues
Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
Participates in process improvement initiatives and performs other duties as assigned
May supervise 1-2 direct reports
Expertise in GxP and appropriate regional clinical research regulations and guidelines
Well developed problem solving, risk assessment and impact analysis abilities

QA Auditor / Senior QA Auditor Resume Examples & Samples

Establish work priorities to meet targets and timelines
Conduct internal process based and system audits for the organization
Follow up on audit response and corrective actions
Review data, records and documents to assess appropriateness of investigation, root cause identification and corrective action activities
Serve as the Quality compliance representative on cross-functional teams
Assists in evaluating regulatory requirement changes, impact to company's operations and make recommendations to management
Support client audit and regulatory inspection activities
Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes and issues
Review and approve quality management records
Participate in discrepancy investigations. Ensure discrepancies are thoroughly identified, defined and properly assessed
Participate in company audit readiness activities
Provide guidance to internal and external customers on best practices for maintaining a quality program
Provide input into the design and presentation of departmental performance metrics

QA Auditor Resume Examples & Samples

Conducts and/or assists a variety of client, internal or GMP audits and regulatory inspections as requested by senior management
Performs directed site audits, and facility audits
Supports senior management for vendor and/or sub-contractor audits
Participates/leads process audits and may participate as a co-auditor in more complex system audits
Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings
Serves as a resources to operational departments on audit or quality assurance
Subject matter
Previous Lab experience and QA experience that provides the knowledge, skills, and abilities to perform the job
Thorough knowledge of GMP and appropriate regional research regulations and guidelines
Perform QA audits of facility records and issue written audits. Records include: Equipment maintenance and calibration work, new or relocated equipment qualification documents (IQ/OQ/PQ), and software validation

QA Auditor Resume Examples & Samples

Successfully plan, schedule and conduct investigational site audits
Assist in and successfully perform all regulatory document reviews (i.e. clinical protocols, Amendments to protocols, Informed Consent Forms, Clinical component to the IB)
Assist in the development, review, approval and distribution of global and local SOP, Work Instructions, forms and templates
Represent GCQA as a member of a product / project team
Assist in establishing training programs and associated documentation
Conduct training as necessary
Assist in the planning, scheduling and conducting of CRO / vendor activities and audits as well as assist in the FDA preparation activities for clinical sites
Assist other GCQA Managers in other duties as required

Senior QA Auditor Resume Examples & Samples

Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
Host customer audits,
Assist in training of new Quality Assurance staff
Strong interpersonal skills
Ability to initiate assigned tasks and to work independently
5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GXP experience

Associate QA Auditor Resume Examples & Samples

At least one year laboratory experience and/or Quality Assurance/Quality Control experience
Knowledge of routine analytical methodologies
Detail oriented and able to comply with written procedures

Principal / Senior QA Auditor Resume Examples & Samples

Effectively Plan and conduct QA audits in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with requirements of ICON/Sponsor Standard Operating Procedures, study protocols and relevant regulations
Maintain a thorough knowledge of all relevant ICON SOPs, Good Clinical Practice guidelines, relevant regulations and ISO requirements
Perform quality system audits and process audits
Perform supplier/vendor audits
Perform contract audits for Sponsor companies
Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented
Assist with the review of audit reports and audit results, and with performing analyses and trending of audit results, as required
Assist with the planning and coordination of specific projects related to the development and Improvement of the ICON Quality Assurance program
Perform lead auditor duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results
Perform QA Review of SOPs, as required
Train and mentor new QA auditors in order for them to perform their function effectively and provide a benchmark of auditing competencies to less experienced colleagues
Liaise with clients and project managers on quality aspects of studies including the attendance at meetings, oral presentations and audits
Assist with business development activities, as required
Coordinate or assist with sponsor audits and regulatory Inspectors, as required
Assist with the management of the department when requested including local project resourcing, assignment of workload, and scheduling and review of audits

Manager, QA Auditor Resume Examples & Samples

Associate’s Degree
A minimum of three (3) years of General Manager experience at a full service property or three (3) years of Executive Committee Member experience
Bilingual: English and one other language
Must be able to speak, read and write in required languages
Working knowledge of Microsoft Word and Outlook
Multi-departmental hotel experience
BA/BS Bachelor’s Degree
Food Safety Certification

QA Auditor Resume Examples & Samples

Experience with QA quality auditing of bioanalytical labs, molecular labs, immunology or similar, clinical, pre-clinical or testing labs
Strong knowledge of GLP
Prefer knowledge of CAP/CLIA

QA Auditor Resume Examples & Samples

Perform product Annual Product Reviews. Assure data is evaluated; trends identified and propose changes as required
Responsible for internal cGMP compliance audits. Performs audits, writes reports, and assists with corrective/preventative actions
Prepares and executes IQ, OQ, PQ validation protocols and reports for facility/utility/product and cleaning validations
Perform tooling assignments for new products
Perform change control assessment relative to tooling and validation requirements
Assists in investigations for non-conformances providing guidance for root cause, corrective and preventative actions
Oversees and assures execution of the calibration program. Performs calibrations as well as assures completion where calibrations are delegated
Oversees and assures execution of the environmental monitoring program. Performs monitoring tasks assuring deviations or alerts are addressed in a timely manner. Assures completion where monitoring activities are delegated
Responsible for maintaining competency for QA Auditor/Validation Tech responsibilities
Responsible for maintaining competency for QA Auditor 1-3 responsibilities
Follow all applicable government regulations including HIPAA, FDA, OSHA, DEA, and EPA
Display behavior which exemplifies employee code of conduct guidelines and Omnicare Core Values

QA Auditor Resume Examples & Samples

Leads site audits, complex process and/or internal systems audits, facility, vendor and/or sub-contractor audits
Serves as resource to operational departments on audit or quality assurance subject matter
Manages departmental projects as assigned
Meets competencies QA Auditor III plus
Excellent training/mentoring experience of junior auditors on a variety of co -audit types
Solid experience with a wide range of GxP audits (e.g. routine, directed, vendor, internal, database, client audits, complex process and systems audits)
Extensive experience in root cause analysis

Senior DRG QA Auditor Resume Examples & Samples

Review and respond to Provider Rebuttals/Appeals on DRG Audits
Document results of Rebuttal/Appeal reviews and provide reports/metrics of the outcomes and review with DRG Audit Managers
Perform individual employee quarterly coding and claim screening assessments to determine if DRG Analyst is maintaining a 95% or better accuracy rate
Monitor client, provider and DRG audit results and make recommendations for additional screening rules/edits
Write executive summary reports on audit compliance recommending quality improvement initiatives and assists with implementing action plans required to maintain departmental standards and all regulatory guidelines
Act as a resource for DRG Management Team and DRG Analysts
Demonstrate commitment to EquiClaim core values

QA Auditor Resume Examples & Samples

Execute program steps through transaction testing and observation of operating activities in compliance with Brink’s standards; remain alert to changing situations, demonstrate flexibility and adaptability in difficult circumstances and continuously strive to achieve a result
Review and ensure compliance with the systems, procedures, rules, objectives and timescales set by the organization (Brink’s Policy and Procedures and local key regulatory requirements)
Approach decision-making systematically and logically, ensuring that all the necessary facts and information are available and accurate, carefully considering the decision, and ensuring that actions are carefully considered and astute
Develop recommended changes in operating procedures and internal controls to correct existing and preclude future exceptions to established norms
Collect information relevant to the problem, exhibit discipline in ascertaining the root cause, identify and develop a practical solution, communicate the findings and help implement action to resolve the problem
Perform other duties as assigned or necessary
Minimum of 1 year experience auditing general security requirements and internal controls
Must be Bilingual (Spanish)
2 years experience auditing general security requirements and internal controls
Business judgment and discretion
Strong consultative, analytical and problem solving skills
Detail oriented, strong organizational skills and ability to work independently

QA Auditor Resume Examples & Samples

Perform QC release of specified reagents and raw materials
Report all quality control issues, including but not limited to: OOSs, deviations, observations affecting processes, consumable / vendor quality, equipment calibration, and training issues to the Quality Manager
Collect and organize data for all laboratory investigations
Collect and organize laboratory validation data
Provide technical support for internal audits
Maintain laboratory safety standards and requirements
Adhere to all laboratory SOPs
Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality System and regulatory requirements for the testing operations
Recommend and implement improvements for procedures and protocol
Adopt work procedures and processes that support company and departmental standards, procedures and strategic directives
Participate in associated GMP training to obtain an understanding of GMP regulations and site SOP requirements
Education: Bachelor’s degree (B.A./B.S.) or equivalent in Microbiology or related field
Experience: 0 - 3 years laboratory experience
Experience with FDA and international Quality System rules and regulations, including planning and implementation, is preferred
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Other: Must have working knowledge of the Quality System. Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing

QA Auditor Resume Examples & Samples

Develops, implements and maintains the division quality principles, systems and controls through the review of departmental documentation including training manuals and standard operating procedures (SOPs) and provides expert commentary on the completeness and adequacy of support for applicable regulatory requirements specific to system compliance under federal guidelines
Maintains the internal audit program which shall include establishing and maintaining audit standards per regulatory and company requirements
Coordinates and hosts customer (client, regulatory, etc.) audits as required
Ensures all inspection and review findings are followed up to completion
Apprises senior staff of audit findings as necessary and initiates discussion with appropriate personnel to resolve issues
Assembles and maintains department quality reports for management review (Field Event Reports, Internal Incident Reports, Audit Reports, etc.), to include track and trend data analysis
Provides analysis of processes to other operational units on a periodic basis
Creates, revises, reviews and approves SOPs for department and other areas as applicable
Reviews and approves validation protocols
Understands and interprets regulatory requirements and guidelines to ensure company compliance, and to maintain certification with regulatory authorities
Participates and / or facilitates continuous quality improvement initiatives / teams
Assist in training new analysts and staff in quality system requirements and applicable regulations
A solid foundation of knowledge in Quality Assurance and Quality Management principles
Effective organizational and analytical skills
Intermediate computer skills

QA Auditor Resume Examples & Samples

Assists manufacturing in maintaining the required quality standards through ongoing inspection
Verifies clearance on production floor
Proofs first sheet off press, at beginning of job, at startup of each shift, and at regular intervals, making quality decisions
Understands the concept of front to back resignation and verification of bar code placement per customer spec
Audits production forms, documentation and inventory job ticket contents
Performs disposition of defective material, write and enter defect reports into the computer
Performs quality checks of execution of bindery roll inserts, folded inserts, folding cartons, and day labels
Verifies proper product running in each area as well as proper size, count, replacement of identifying labels and proper packaging
Processes the job ticket at the end of the job; including disposition of samples, tailgate samples and Certificates of Analysis (C of A)
Stages the job tickets in the proper production box
Performs C of A review for paper and ink
Operates the AVIA or Eye-C proofreading system to complete comparisons
Uses Company supplied PPE equipment when necessary
Ensures compliance with federal, state, company policies & safety rules
Audits all operator processes against Standard Operating Procedures; including challenging the electronics of the machines at required intervals
Verifies product integrity to job specifications – structure, color, size, layout, etc. using variety of tools, measures and methods
Identifies suspect product by completing and placing a hold tag on the load
Reads and understands the combo and job tickets for quantities, selection numbers, size specifications, or other customer specifications and production paperwork before beginning the job
Performs final inspection of folding cartons and complete associated paperwork to ensure compliance with American National Standards Institute (ANSI) standards
Reports any questions or problems to the Quality Assurance Manager
Collects and visually inspects customer samples for color variance, size, and cosmetic defects before forwarding to sample area for processing
Releases jobs to the shipping department as needed
Completes required job and weight count reports daily
Performs final inspections for specified customers
Weighs jobs for count verification
Must have high school diploma or general education degree (G.E.D)
Must have minimum two years’ recent experience in graphic arts in quality, print/packaging, or the equivalent technical or vocational experience in quality processing
Must be able to read a ruler
Must pay close attention to detail
Must be able to meet deadlines in an environment where interruptions occur
Must be reliable and dependable
Must be able to distinguish colors to inspect product
Must pass color vision and color hue tests
Must have ability to make quality decisions by relying on available information training
Must be able to use Microsoft software and ERP system. Must be willing to work overtime as needed; significant overtime may be required during busy periods
Must be able to communicate well with people
Must have above average interpersonal skills
Must be able to perform essential functions of job with or without reasonable accommodations

Lead Internal QA Auditor Resume Examples & Samples

Support the NuVasive QMS internal audit program by identifying audit needs and performing audits of internal US and international NuVasive affiliate sites. These audits will vary in frequency, scope, and depth depending on business and compliance requirements, and will be customized to the capability, performance, and risk levels of the auditee organizations
Schedule and conduct internal audits in the capacity of lead auditor, in accordance with internal procedures. Present the internal audit program to external auditors. Audits will typically be performed to evaluate conformity with ISO 13485, 21CFR820, 21CFR1271, AATB, MDD, CMDCAS, and other relevant external standards and regulations, as well as interal Quality Manual and related procedures
Administration of the internal audit program will include the development of internal audit schedules, classifying the audit subjects based on risk and previous audit performance levels
Document and track assigned audit observations and recommendations to closure through the corrective action (CAPA) system, and provide leadership and guidance to members of the organization in the resolution of quality system deficiencies in accordance with regulatory requirements and standards
Schedule, track and complete effectiveness checks as needed for both corrections and corrective action (CAPA) activities
Develop action plans intended to support the global internal audit strategy

QA Auditor Resume Examples & Samples

Perform and execute internal and external audits
Perform in-process tests and calculate batch adjustments
Train operators
Perform QA activities including: OOS, CAPA, Manufacturing Investigations
Propose improvement actions and report regularly on implementation progress
Review SOP's for accuracy and compliance- redraft and revise when needed
Support customer and regulatory audits

QA Auditor Resume Examples & Samples

Perform protocol, data, interim data release, final report audits, as well as in-life phase inspections to ensure compliance with GLPs, internal SOPs, and Sponsor requirements
Perform internal facility and process audits, as well as subcontractor and vendor inspections and audits
Ensure that equipment and software validations are in compliance with 21 CFR Part 11
Represent Quality Assurance during inspections from clients and regulatory agencies (e.g. FDA, EPA, OECD, CLIA)
Maintain accurate and organized QA records, properly indexed quality assurance records, including protocols, correspondence, inspection/audit status reports, audit logs, and other QA records
B.S. Biology, Chemistry, or other Analytical Science
At least three years of experience with QA Auditing (GLP) at biologics/biotech company (i.e. large molecule)
Excellent knowledge of bioanalytical regulations from the FDA, EMEA, JP, BP, as well as experience with method validation and ISR
Ideally, candidate will have worked in a laboratory setting and subsequently moved into a QA role
Experience with Watson LIMS, CLIA, and GCP are a plus

QA Auditor Resume Examples & Samples

Review, approval, and logs: Change Controls: Investigations of Deviations, Incidents, and OOS & OOT
Review and Approve CAPAs and Investigations
Train personnel on cGMPs and SOPs
Review and approve internal SOPs, policies and guidelines and write QA SOPs
Independently lead audit planning, conduct and report on Quality Assurance routine and non-routine audits of activities, data, internal facilities and processes in GxP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements
Handle non-routine audits that will include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope
Support other auditors in planning, conduct and reporting of audits
Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
Participate in regulatory inspections in core and supporting roles
Acts as Subject Matter Expert / Point of Contact to provide expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures

QA Auditor Resume Examples & Samples

.Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor
Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures
Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures
Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards
Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services
Inspect materials and supplies for compliance with specifications

QA Auditor Technician Resume Examples & Samples

High School Diploma or equivalent with good verbal and written communication skills
Experienced with Microsoft Word, Excel, and PowerPoint
2 or more years of fab experience or equivalent manufacturing experience
Attention to detail and process conformance with conviction to enforce Cypress procedures
Continual improvement mindset with focus on customer expectations and product quality
Able to work successfully as an individual and on teams, and the ability to multitask

Principal QA Auditor Resume Examples & Samples

Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations
Spanish Fluency Required(Read, Write, Conversational)
Leads process audits and may participate as a co-auditor in more complex
Serves as a resources to operational departments on audit or quality assurance subject matter
Prepares and presents audit findings and/or other related information at
Candidates with pre-inspection and inspection FDA audits are preferred

Senior QA Auditor, GCP Resume Examples & Samples

Understand the drug development process
Lead and coordinate diverse audit teams
Accountable for accuracy of audit findings
Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs , and Pharmacovigilance
Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards
Maintain a working knowledge in the specific areas related to GCP compliance including, but not limited to regulatory US FDA regulations/guidance documents and ICH guidelines
Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions)
Perform qualification, and routine compliance audits of clinical suppliers (CROs, phase 1 units, IRBs, translators, depots, etc.)
A strong understanding of GCP regulations and an ability to apply them to clinical research and/or related processes is required
Inspection experience in hosting or supporting regulatory authority inspections (US FDA, Health Canada, EMA, MHRA)
Experience in auditing for compliance of computer system validation (CSV), pharmacovigilance systems, Good Clinical Practice, Central Laboratories and nonclinical GLP is highly desirable
Excellent technical writing skills
Strong Communication skills (written and verbal), interpersonal and problem solving skills and detail oriented

QA Auditor Resume Examples & Samples

Conducts and/or leads a variety of client, internal or GMP audits and regulatory inspections as requested by management
Leads directed facility, vendor and/or sub-contractor audits
Provides GMP consultation and support to PPD project teams and external clients
Leads process audits and may participate as a co-auditor in more complex system audits
Performs other types of QA audits or activities as defined by management
Serves as a resource to operational departments on audit or quality assurance subject matter

Clinical QA Auditor / Manager Resume Examples & Samples

Requirements include degree in nursing, pharmacy or allied health/science and 4-6 years pharmaceutical industry experience within the Quality, Regulatory, or Clinical disciplines
Experience in global GCP, GPvP and/OR CFR/Annex Part 11 auditing: clinical report, clinical investigational site, clinical vendor and drug safety/PV vendor is a must
Knowledge of clinical safety and clinical trial management systems (e.g. Argus, ARISg, TrialWorks, IMPACT) as well as standard tracking databases (e.g., TrackWise, LIMS) is desired

Lead QA Auditor Resume Examples & Samples

Mil-Std-1689
Tech-Pub S9074-AQ-010-BIB/248
ASME Section V & IX (Welding & NDT)
ASME Section I, III & VIII (Fabrication of pressure vessels & components)
NAVSEA Tech-Pub S9074-AR-010GIB/278
Tech-Pub T9074-AD-GIB-010/1688
AWS D1.1

QA Auditor & Compliance Specialist Resume Examples & Samples

B.S. in microbiology, biology, biotechnology, or related discipline
Minimum of 4-6 years of relevant experience in a bio-pharmaceutical / biotechnology regulated environment
At least 2 years focused in a quality assurance or regulatory compliance area
Knowledge of US, EU and cGMP regulations and guidance is required
Knowledge and experience with electronic systems such as Trackwise®, MS Word, PowerPoint, electronic document management system and Excel is preferred for this position

Senior QA Auditor Resume Examples & Samples

Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor
Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures
May participate in inspections and audits of subcontractors, vendors, and suppliers of products and services
Assist in developing and providing basic and advanced regulatory training to QA and operations personnel
Assist with review and revision of QA SOPs to reflect current practice
Participate in collecting and reporting of quality metrics
Serve as the lead in completing Regulatory Affairs and Compliance projects
Other:Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing

QA Auditor Resume Examples & Samples

Verifies that product meets customer requirements prior to being placed in stock or shipped to customer
Conducts plant wide product audits
Conducts process audits where applicable
Performs documentation audits as directed by Quality Manager
Data input as required. Verifies that required logs are being maintained
Performs other quality related tasks as required by Quality Manager
Provides back-up and training as requested by Quality Manager
May assist in root cause analysis and assist in resolving problems
Interfaces with customer regarding quality issue(s), as necessary
Stops production when required if product(s) do not meet customer requirements
Associates degree preferred or High School diploma AND
One to two years related experience and/or training OR
Skills including reading comprehension of quality procedures, mechanical drawings, and other specifications
Ability to record, organize and report data
Ability to use and understand sampling plans, elementary industrial statistics and basic inspection tools
Special knowledge including operation of computers, windows, Microsoft office, SAS, copier, printers, basic statistical methods, internal auditing techniques, knowledge of ISO requirements
J-Standard-001D and IPC 610D knowledge required
This is a manufacturing position AND and office based position

QA Auditor Resume Examples & Samples

Bachelor’s degree in medical technology or clinical laboratory science or chemical, physical, or biological science or Associate’s degree in clinical laboratory science (certified MLT/CLT) and 10 years’ laboratory experience
5 years of clinical or forensic laboratory experience in a moderate/high complexity laboratory or 2 years of QA/auditing experience in a laboratory, hospital, bio-tech, medical device or science or healthcare related field
Certified Quality Auditor (ASQ) or equivalent certification is required or must be obtained within the first 12 months. Additional certifications and specific training may be required depending upon primary responsibility (RQAP-GLP, CQM/OE, ISO, FDA GxP)
Strong verbal and written communication skills with attention to detail and accuracy
Certified Medical Technologist (MT)/Clinical Laboratory Scientist (CLS)
Knowledge of and experience with laboratory accreditation requirements, including CAP, CLIA, NY State, and SAMHSA (NLCP)
Proficient computer skills including Microsoft Office Suite programs (Word and Excel)
Plan and conduct the internal audits of the technical activities of the Clinical/Anatomic Pathology and Forensic (Workplace Drug Testing) Laboratories
Monitor/audit the performance of critical/key laboratory vendors, as needed
Plan and conduct internal audits of administrative departments, including, Client Services, IT, Facilities, Warehouse/Shipping, etc. to assure management that practices, records, controls, and SOPs are in compliance with regulations and accreditation requirements
Follow the direction of the Director, Quality Systems to maintain the overall Quality Management System

QA Auditor Resume Examples & Samples

Monitor the production processes and ensure consistency of procedures
Review/approve the right product or components for use in production
Check incoming components for conformance to specifications
Perform visual inspection of finished product
Perform verification of machine setting for inspection line
Pull and prepare finished product retain samples
Audit the maintenance of a clean and sanitary environment
Perform annual product review of retained samples
Measure or check incoming packaging components for conformance to specifications
Review, approve and issue green release stickers to operations
Or equivalent combination of education and experiences

QA Auditor Resume Examples & Samples

Plans and performs assigned internal audits approved by senior management
Generates and distributes the audit report within the required timeframe
Assists SMEs with initiating CAPAs within the required timeframe in accordance with procedures
Reviews and follows up with the responses within the required timeframe for all types of internal audits
Provides feedback to the audited departments and upper management on compliance to GMP (QSR) Regulations (21 CFR Part 820; 210; 211 &1271), FDA Aseptic Processing Guidance , ISO 13408, 9001, 13485 standards, and European Union Medical Directives
Participates in the development of action plans to correct deficiencies and improve quality processes
Supports regulatory or client audits as host, front room or backroom manager
Supports management of CAPAs related to internal audits, customer audits, and regulatory inspections
Revise or approve SOPs related to audit observations and audit program
Assigned duties according to specified procedures and receives detailed instructions
Performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments
Receives little instruction on day-to-day work and receives general instructions on new assignments
Establishes methods and procedures for attaining specific goals and objectives, and receives guidance in terms of broad goals. Only the final results of work are typically reviewed
Exercises wide latitude in determining objectives and approaches to critical assignments
Bachelor’s degree in life sciences required. Preferred area of study: Life Sciences
Experience greater than 6 years direct QA experience and a working knowledge of cell culture and aseptic processing experience required
Minimum 5 years experience in performing internal audits and third party audit management required
Experience with oversight of aseptic processing and the associated international
Aseptic processing regulations and medical device regulations
GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance knowledge preferred
Working Knowledge of endotoxin testing required
Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented
Independent work skills and a strong work ethic
Ability to interface and communicate directly with clients may be required
Microsoft Office and database management skills, organization skills, record keeping
Ability to handle multiple projects
Strong collaboration and communication skills required. Ability to multitask and sense of urgency a must

QA Auditor Resume Examples & Samples

Plan, conduct, report, and oversee resolution of directed audits in collaboration with other GQ&C staff and/or client QA personnel
Lead/manage investigation efforts, evaluate documentation/evidence, provide guidance, and work in collaboration with applicable department(s) and other GQ&C staff regarding potential scientific misconduct and significant non-compliance cases
Serve as a primary contact for consulting to internal PPD staff on issues of GCP compliance as well as PPD procedural compliance. Participate in PPD improvement initiatives on behalf of PPD GQ&C as necessary
Review and provide comment on study documentation as needed, such as client site audit responses, master ICF, site level CAPAs/Performance Improvement Plans, Training Materials, PPD procedural documents, and client SOPs
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’ for QA II and 5+ for QA III level) or equivalent combination of education, training, & experience
Conducts and/or leads a variety of client, internal or GCP audits and regulatory inspection support as requested by senior management
Leads directed site audits and/or sub-contractor audits
Provides GCP consultation and support to PPD project teams and external clients

QA Auditor Resume Examples & Samples

Conducts internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations
Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory audits and file audits for clients and projects
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience
Meets competencies for Associate QA Auditor plus
Detailed knowledge of GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
Demonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH
Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reports
Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
Very good problem solving, risk assessment and impact analysis abilities
Proficient at negotiation and conflict management

QA Auditor Resume Examples & Samples

Conducts complex internal audits and inspections of the Phase I Clinic to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations
Leads or assists with client audits of PPD and supports regulatory inspections at the Phase I Unit
Leads or assists with contract vendor audits, remotely as well as on-site
Acts as a knowledgeable QA and GCP resource/consultant to Phase I operational departments
Performs other activities in support of QA as assigned by Management
Generates audit reports, codes findings for trend analysis and facilitates root cause analysis with Clinics staff. Documents audit findings and ensures audit findings are properly closed out
Bachelor's degree in a science/healthcare field or equivalent and relevant formal academic / vocational qualification
Minimum of 4 years of clinical research with at least 1.5 years in direct experience in GCP auditing
Certified quality auditor in a professional association such as ASQ
Experience working in a Phase I Clinic is especially desirable
Successful completion of PPD Fountation Training after hire
Meets competencies QA Auditor I plus
Thorough knowledge of GCP and appropriate regional clinical research regulations and guidelines
Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management
Able to work independently or in a team environment
Good interpersonal skills, ability to work with all levelos of personnel and management
Flexible and able to multi-task and prioritize competing demands/workload

QA Auditor, Servicing Resume Examples & Samples

Coordinate and complete assigned audits for GSE (Fannie, Freddie, HUD, VA) and non-GSE (Treasury) servicing requirements
Independently complete reviews that are targeted in scope by servicing functional area and / or specified servicing processes (Non-Default and Default areas)
Identify and report on compliance and operational defects or violations of the specific audited program to lines of business and senior management
Performs risk assessments and/or transactional testing of loans selected to evaluate, analyze, and assess risk and to detect errors and omissions, as well as violation of line of business policies and procedures. The audit includes, but is not limited to, review of data and documentation for accuracy and consistency, systems analysis, regulatory compliance assessment and investor program requirements, as applicable. (50%)
Gather, investigate, and review additional information and conduct additional research and/or testing as necessary, including targeted reviews. Ensure audits are performed in a timely manner in accordance with established procedures and investor guidelines. (25%)
Create and maintain various reports and project plans to meet departmental and auditing requirements. Meet with management to review findings and remediation related operational audits conducted. (25%)
College Coursework or Equivalent
Strong organizational, analytical and problem solving skills
Team oriented and flexible

QA Auditor Resume Examples & Samples

BS or Equivalent
5-7 years direct auditing experience, preferably in the field of biotechnology and immune-oncology
Ability to assess multiple vendor types, including raw material suppliers, contract laboratories, manufacturers and distributors for GxP compliance
Preference for auditor able to support GCP, GLP and GMP functions

Chemistry QA Auditor Resume Examples & Samples

Maintain the Quality Laboratories computer systems (e.g. administrator, manage accounts, complete PMs) and ensure cGMP compliance of electronic data
Perform the independent data review of testing forms and batch records
Responsible for initiating, performing, documenting and approval of laboratory related validations and technology / test method transfers
Instrument troubleshooting and maintenance
Review and edit laboratory documents including SOPs, batch records and testing forms
Actively support Operational Excellence (Lean / Six Sigma) activities and be accountable for sustainability and continued development in the work area
Incorporate best practices from Operational Excellence, industry practices into the laboratory environment to prevent reoccurring events
Provide input on opportunities and issues to management as necessary
Work on special projects as they arise
Thorough knowledge of the various instruments with demonstrated expertise on the technical instrumentation used in the lab, specifically HPLC and GC including: validation, theory, preventative maintenance, and trouble shooting. Individual must have knowledge of global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada)
Must have lead and successfully completed projects. Demonstrate project abilities in proficiency evaluation and certification programs including knowledge in USP terminology and requirements and has exhibited the ability to apply standard principles, methods, and techniques in resolving technical problems. Must have good interpersonal and communication skills to successfully perform all aspects of training, scheduling and project management
The incumbent must be able to work effectively with all levels of individuals within the organization (interdepartmental, cross functional, Research and Development) and have exhibited a high level of personal maturity and professional judgment
Must be self-directed and demonstrate an ability to work independently in prioritizing data review and project development based on department needs. Possess strong time management and effective writing skills, highly organized and be a critical thinker. Must have strong technical and/or leadership skills with good analytical and problem solving skills. Demonstrate a high degree of initiative and flexibility. Must be able to multi-task and work in an ever-changing fast-paced environment
Qualification as a Senior Chemistry technician is preferred. Working knowledge of IsoTrain, Lean concepts, Lab Investigations and respective corrective preventive action systems (TrackWise / LIR / CAPA) preferred
Bachelor’s Degree is required: Chemistry, Chemical Science, Engineering, Biology
Must have a minimum of 3 years of experience in a Quality Control role as a chemist, and/or previous experience in data review or peer review in an FDA regulated environment

Senior QA Auditor Resume Examples & Samples

 Facilitate sponsor audits / regulatory inspections, as assigned
 Fosters a good working relationship with internal and external clients
 Plan and conduct audits, including global and complex assignments, delivering a written report
 Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate 
 Mentor and assist with training of less experienced auditors
 Travel on assignment
 Ability to develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s business
 Excellent interpersonal, verbal, and written communication skills, including ability to present at conferences, meetings, training sessions
 Excellent analytical skills
 Ability to manage multiple and varied tasks, and prioritize workload
 Motivated to work and perform consistently in a fast-paced environment
 Ability to execute strategy and plans
 Ability to diplomatically address sensitive issues confidentially and professionally
 Excellent problem solving and negotiation skills
 Effective at analyzing problems considering the ‘big picture’ and recommending

Manager, QA Auditor Resume Examples & Samples

High School Degree/GED
A minimum of five (5) years of professional experience
A minimum of five (5) years of managerial experience
A minimum of three (3) years of General Manager experience at a full service property or a minimum of three (3) years of Executive Committee Member experience at a Full Service Hotel
Multi-departmental Full Service Hotel experience
Ability to travel as required, including continuous travel to properties
Bilingual – English and one other language
Must be able to speak, read and write in preferred languages

QA Auditor Resume Examples & Samples

Proficient in Microsoft Office products (Excel, Word, PowerPoint)
Proven ability to analyze data and determine anomalies
Ability to carry out assignments to completion within defined parameters, prescribed routines and standard accepted practices
Strong organizational, analytical and problem-solving skills
Ability to function independently and prioritize workload
College Coursework or equivalent work experience
3+ years

Associate QA Auditor / QA Auditor Resume Examples & Samples

Identifies and addresses non-conformance issues
Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-1 year for Associate level and 1-2 years’ for QA Auditor I) or equivalent combination of education, training, & experience
Successful completion of PPD Foundation Training(if applicable)
Meets competencies for Associate QA Auditor(if applicable) plus
Guidelines and to all other standards or guidelines applicable to business-related requirements,
Demonstrated ability to independently review study documents for compliance with regulatory requirements or PPD procedures (e.g. Informed consents, protocols, CRFs, Source Document Templates, method validations, equipment qualifications)

QA Auditor, Out of Network Medical Claims Resume Examples & Samples

Perform daily audits and follow standard processes and procedures for assigned positions
Identify recurring issues for review and recommendations
Display basic understanding of standard review processes and work flows, providing consistency and appropriate detail in alignment with all policies and procedures, business rules and overall department guidelines
Maintain consistent quality and production standards with consideration around specific audit and turnaround time expectations
Demonstrate Company’s Core Competencies and values held within
Minimum HS Diploma (or GED)
Minimum 1 year related industry experience
Quality assurance experience preferred
Knowledge of claim payment and process preferred
Knowledge of insurance or healthcare industry
Knowledge of methodology for multiple position in order to identify issues
Communication (written, verbal and listening), attention to detail, interpersonal and analytic skills
Ability to maintain consistent quality and production standards
Individual in this position must be able to work in a standard office environment which requires sitting and viewing monitor(s) for extended periods of time, operating standard office equipment such as, but not limited to, a keyboard, copier and telephone

Senior QA Auditor / Risk Adjustment Resume Examples & Samples

Perform a detailed review of medical records to ensure the ICD-10-CM code(s) was coded correctly during the coding and / or auditing process
Document audit findings in database and/or MS Excel
Increase coding accuracy of coders and auditors
Ensure auditors are auditing in accordance with guidelines
Reviews and analyzes medical record documentation in accordance with established industry and government regulations, AHA Coding Clinic, and departmental policies and procedures
Ensures the accuracy, integrity and quality of coding selections per established regulations, and they are supported by documentation, within the body of the medical record
Execute the tactical day-to-day activities of the Quality Assurance process
Perform, summarize and report on the Quality Assurance audits
Creates performance improvement plan as needed
Mastery of Optum coding guidelines, applications and practices. Subject matter expert
Review QA findings with individual coders. Provide coaching and mentorship
Analyze QA results and create reports
Collaborate with training department to develop training materials based upon QA results
Communicates with management regarding audit findings
High School Education or equivalent experience
CPC, CPC-H, CCS, CCA , RHIT, or RHIA Certification
5 or more years of Medicare Risk Adjustment Coding Experience
Advanced knowledge of medical terminology, pharmacology and anatomy and physiology
Knowledge of Risk Adjustment Hierarchal Condition Category Methodology
Basic Knowledge of MS Word, PowerPoint, Outlook
Intermediate Excel Skills
Previous Risk Adjustment auditing experience
Ability to problem solve
Ability to work independently in a fast-paced environment with minimal supervision and guidance
Ability to prioritize, strong organizations skills with an attention to detail

Associate QA Auditor Resume Examples & Samples

Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in EDA (audit demographics, dates, and personnel,), performing data reviews, file audits, etc. as directed, entering and categorizing audit findings in the QA audit tracking database, soliciting follow-up information and closing audits/findings in the QA tracking database
Assist in review of corrective action plans for completeness and accuracy
Obtain a fundamental knowledge of current GXP regulations, guidelines, and related auditing techniques
Bachelor’s/primary degree with 1 year Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; or equivalent combination of education, training and experience
Ability to establish and maintain effective working relationships with coworkers, managers and client

E QA Auditor Nalc Sun, Mon, Sat Resume Examples & Samples

Contribute to efforts to implement nonconforming material resolution steps
Acquires basic skills to perform routine tasks
Typically requires a high school diploma or equivalent

Senior QA Auditor, Phase Resume Examples & Samples

Plan, schedule, conduct, report and close audit activities for the QuintilesIMS Phase I Clinic, Clinical Pharmacology/PK Services and at other Phase I vendor sites as needed. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions
Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
Prepare and review and approve corrective action plans
Host customer audits
Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed
Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time
Travel required, may include international travel

Medical Technologist / QA Auditor Resume Examples & Samples

1 to 4 years of Medical Technology bench experience required in a CAP/CLIA certified laboratory setting
Registration with the American Society of Clinical Pathology (ASCP), at a generalist level is preferred but other areas can be considered
Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) along with good interpersonal skills
Superb knowledge of Laboratory Quality Systems
Basic computer skills in Microsoft Word, Excel and PowerPoint

QA Auditor Team Lead Resume Examples & Samples

Allocate assigned resources to conduct reviews
Interact with each auditor daily via phone call, walk-about or GoToMeeting
Serve as first point of escalation (level 2) for audit disputes
Partner with staff and other leaders to develop improvements (e.g., process, quality)
Assume accountability for ensuring individuals and the team meet their performance metric goals
Hold staff one-on-one and monthly team meetings
Attend meetings as scheduled
Create presentations and communicate them to leaders cross-functionally
Experience in healthcare insurance billing
Ability to prioritize multiple projects simultaneously
Ability to effectively communicate data and presentation information to senior leadership and team members
Experience in Microsoft Office suite of applications including Excel (formatting formulas, managing data, and filtering results)
Experience in an Auditing capacity conducting root cause analysis
Word (creating and editing documents), PowerPoint (creating and editing presentations)
High School Diploma or GED from an accredited institution
Associate degree from an accredited institution

QA Auditor Manager Resume Examples & Samples

Dream Big, Plan Wisely
Break Down the Walls
Think Critically, Speak Up, Deliver with Pride
Inspire Through Trust, Lead By Example
Be Unstoppable
Manage QA Auditors to conduct process reviews and provide oversight in the creation and facilitation of audits across multiple operational areas
Ensure individuals and the team meet or exceed performance goals
Direct employees in matters of quality and inspection, and assist in disciplining personnel when standards are not met
Maintain procedures and programs to ensure Operational units meets organizational and regulatory standards for proper function, quality, and Member/Provider acceptance
Produce, analyze and interpret reports on trending of audits evolutions and summarize to operations leadership
Serve as point of escalation for audit disputes
Conduct comprehensive needs analysis to ensure that audit programs fulfill the needs and objectives of the company
Partner and consult with internal organizations to create and execute audit plans
Contribute to creating new processes or services to optimize operational areas
Contribute to the overall success of the Quality Assurance Organization by identifying ways to continuously improve the learning process
Hold staff 1:1 and monthly team meetings
Ensure team supports and adheres to all improvement initiatives
Monitor and manage staff member performance
Provide coaching to quality staff based on quality production/service results and develop improvement plans when needed
Maintain high morale by inspiring representatives through reward and recognition programs
Investigate trends, identify root problem, report issues, and collaboratively works with specific team/individuals to resolve issues
Supervise department staff including recruiting, hiring and training staff
Demonstrate or develop deep understanding of all Operations processes and supporting systems
Previous work experience in an auditing function conducting root cause analysis
Experience supervising a team of employees, both direct and indirect teams (30-40 employees)
Demonstrated experience developing and performing tests; implementing statistics and process control tools; and maintaining effective compliance and corrective action procedures
Demonstrated knowledge in creating reports, surveys and quality audits for management or external clients
Experience communicating with cross-functional individuals within an organization
Experience leading project groups and independent projects within a corporate setting
Skilled in creating documents, Vlookups and pivot tables within Microsoft Excel
Experience creating presentations using Microsoft PowerPoint
Exposure to corporate email and Microsoft Word by creating and editing documents
Experience with troubleshooting and process improvement
Knowledge of at least two or more lines of business such as Medicare NY/NJ, Medicaid, Family Health Plus, Child Health Plus, NH Family
Experience managing a Quality Assurance team
Experience in Healthcare/Health Plan customer service and claims processing
Demonstrated experience or deep understanding of healthcare Operations processes and supporting systems such as Claims Processing, Enrollment & Billing, and Member Services

QA Auditor Resume Examples & Samples

Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Quintiles contracts to assess compliance with applicable regulations/guidelines, customer requirements, Q Squared Solutions' SOPs and project specific guidelines/instructions
Assist in preparation and review of corrective action plans
Document and report quality and compliance issues to QA management according to required timelines
Advise quality assurance management on system audit needs
Assist in preparation and review of corrective action plans associated with customer audits
Bachelor's degree with a minimum of 3 years experience in a quality assurance, specifically in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience; or equivalent combination of education, training and experience
Considerable knowledge of GXP regulations and quality assurance auditing techniques

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