Compliance / Quality Specialist Resume Samples

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B O'Connell

Bonita

O'Connell

4660 Legros Villages

Chicago

+1 (555) 966 9788

4660 Legros Villages

Chicago

Phone

p +1 (555) 966 9788

Experience Experience

Houston, TX

Compliance / Quality Specialist

Houston, TX

White-Pouros

Houston, TX

Compliance / Quality Specialist

Escalates and works with senior management on resolutions to overdue quality items or any negative trends identified
Communicates and works with all levels of management
Initiate and develop relationships with internal/external constituencies and provide support
Works with the team to develop robust training programs
Defines and develops agendas for quality-related meetings and participates as necessary
Leads and manages Change Controls for External Manufacturing
Authors and reviews quality communications (e.g., policies, procedures, and training) and makes recommendations for updates and edits

Detroit, MI

Quality Assurance Compliance Specialist

Detroit, MI

Swaniawski-Baumbach

Detroit, MI

Quality Assurance Compliance Specialist

Revise or create standard operating procedures on work stations and/or improve their systems and provide trainings
Work with R&D during new product development and Production/Maintenance during new equipment shake down to assure adequate specification development
Work closely with Moonachie plant to assure continued improvement of quality through communication and review of product compliance to specification
Create proposals for customers and take care of financial management
Assist QA Manager with records maintenance and storage relating to Product Recall Program
Participate in quality and process improvement initiatives, and project teams
Develop, check or revise pharmaceutical Quality Agreements; for example compare contests with standard operating procedures or other internal Regulation

present

Phoenix, AZ

Quality Specialist, Systems & Compliance

Phoenix, AZ

Casper Group

present

Phoenix, AZ

Quality Specialist, Systems & Compliance

present

Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
Other duties as requested by management
SOP and CJA development and review
Conduct periodic shop floor audits to ensure cGMP compliance
Ensure proper control of materials via product investigations
Review incursions into classified areas for process and environmental impact and approve accordingly
Author and review SOPs specific to the IPT

Education Education

Bachelor’s Degree in Other Discipline With Relevant Experience

University of North Texas

Bachelor’s Degree in Other Discipline With Relevant Experience

Skills Skills

Strong attention to detail
Strong analytic skills and ability to work in a team and collaborative environment
Knowledge of healthcare industry and billing/reimbursement practices
Excellent written and verbal communication skills
Strong grammar, usage, proofreading and editing skills
Ability to manage multiple projects and deadlines
Previous regulatory, compliance and/or quality assurance experience
Proficient in MS Office applications
Ability to work independently as well as in a team environment
Strong analytical and problem-solving skills

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Quality Assurance Compliance Specialist Resume Examples & Samples

2+ years of related experience at a Pharmaceutical, Biotech, or Medical Device company; 1+ year of experience working in a cGMP lab environment
Basic knowledge of GMP regulations
Degree in a Scientific related field
Experience with Microbiological Testing or Environmental Monitoring
Previous experience with Lab-based Data Management systems

Compliance Quality Specialist Resume Examples & Samples

Responsible for maintaining or achieving certifications for production areas
IPEC – Member
Responds to compendial / regulatory issues
Validation / Qualification advisor
GMP coordinator /auditor (excipient, food additive, etc.)
Auditor for supplier and contractors/tollers
Raw material supplier qualification and spec. development
Regulatory audit liaison – FDA, Rabbi, Halal, etc
MOC and GMP project approver
COA notes author/approver
Batch Record Review approver
Product Quality Champion
A minimum of 3 years of regulatory experience in a manufacturing environment
Knowledgeable in quality assurance systems, statistical quality control & procedures, chemical plant processes, cGMP guidelines & regulations, and ISO-9001:2008 standards
Must be authorized to work in the United States
Understanding of FDA regulations and BRC, EFfCI, and EXCiPACT standards
Experience with Quality Risk Management, Change management and excipient regulations
Experience in leading and organizing internal and external (customer and 3rd party) audits

Quality Specialist, Compliance Resume Examples & Samples

Manage customer experience reports (complaints) in compliance with applicable regulations
Receive, initiate, document, coordinate the investigation and close the complaint files accordingly
Experience in clinical data management
Strong analytical, planning and personal organization skills
Fluent in English and preferable two other languages (German & Chinese preferred)

Quality Assurance Compliance Specialist Resume Examples & Samples

Review and approve Non-conforming events (NCE) and CAPAs
Pre-review/ approval of pre-executed batch records for assigned clients
Post review of MFG batch records if required
Review / approval of MFG COA’s
Perform timely review of complex study files, such as: Assay Validations, Process Validations
Interact with MFG management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management
Interact with project team to assure that project requirements and details are understood and effectively translated into MFG records
Interact with QA batch record reviewers to communicate project requirements and assure that details are adequately translated into MFG records
Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
Write and revise SOPs as necessary
Review and approve document change requests
Equipment Validation (IQ, OQ, PQ) and Change Control review/approval
Coordinate execution of Manufacturing Suite inspections
Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections
Contact for on-site client visits. Participate/Lead to support internal and/or client audits
Coordinate with Project teams in design, set up and execution of projects
Review protocol and specifications for understanding and execution of orders
Facilitate and assure timely and accurate completion of pre and post executed batch records
Focused QA Representative for review/approval of Final Reports, CoA’s, Non-Conforming Events (NCEs) and CAPA’s. Ensures site adherence to Quality Systems
Scientific, Laboratory, and/or Production experience required. Extensive experience is highly preferable
Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required
Knowledge of FDA PTC & MHRA Out-of-Specification guidance documents required
Knowledge of Root Cause analysis techniques required
Extensive experience writing and/or reviewing/approving Laboratory Investigations / Deviations / CAPA’s preferable
Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations

Quality Assurance Compliance Specialist Resume Examples & Samples

Perform timely review of complex study files, such as: Assay Validations, Process Validations, and Viral Clearance
Compiles and reviews laboratory data or manufacturing batch records in accordance to cGxP and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained
Performs Equipment Validation (IQ, OQ, PQ) and Change Control review/approval
Performs Laboratory and Manufacturing Suite inspections
Focused QA Representative on review/approval of Final Reports, CoA’s, Non-Conforming Events (NCEs), Investigations (OOS), and CAPA’s; will coach/mentor Laboratory personnel in development of technical writing skills. Ensures site adherence to Quality Systems

Quality Assurance Compliance Specialist Resume Examples & Samples

Be responsible for assessment of impact, review of investigation for compliance to internal and external requirements, assignment and approval of CAPA, and disposition of any impacted products
Review and approve Batch Production Records, Utilities and Maintenance Deviations, Site Drawings, Calibration additions/revisions, PM additions/revisions, and Standard Operating Procedures for all manufacturing operations inclusive of: parenteral filling, parenteral compounding, solids packaging, solids tableting, Powders, Pour-Ons, Chewable technologies or API production areas. Reviews and approves QC Laboratory Validations, test methods and SOPs. Technical and compliance input is given directly to all of his/her supported areas impacting the quality of the manufactured products
Review and approve the validations for the production areas and
College-level education in a related scientific field(such as biology, chemistry, microbiology, or biochemistry)
A minimum of six years of pharmaceutical industrial experience and should include “hands-on” experience in quality assurance, quality control and manufacturing
A good academic or working background in statistics, a working knowledge of Validation and “hands-on” experience in audits
Must be knowledgeable of current regulations (i.e.,FDA, EPA, USDA, cGMPmp, etc.) regarding quality practices for the manufacture and development of sterile, solid dose, and non-sterile drug products and must be able to apply these regulations to the facility in an expeditious and economic manner
Must have good organizational/communication skills and the ability to interact with diverse departments to initiate and complete projects in a timely manner
Strong decision-making abilities and the knowledge as to when to involve management are essential

Quality Control Compliance Specialist Resume Examples & Samples

Identify and assist in correcting Quality Control deficiencies within the Department as it relates to Federal, Agency, Investor, and Regulatory requirements
Assist in the coordination of on-going Quality Control Department review of audits for completeness and consistency
Review various department audit question sets on a monthly basis in the audit system and electronic record retention to ensure accuracy
Assist in the oversight and the preparation for and coordination of state, investor and/or agency audits
Review handbooks, selling guides, agency and investor recommendation and requirements etc. for changes related to Quality Control, as needed
Review and research as necessary Investor certification language to ensure DHIM Quality Control Plan, Policy and Procedures meet all requirements prior to the Quality Control Managers Certification
Assist in the preparation, monitoring and updating of the Quality Control Department Project List
Interact directly with Agencies and/or Legal counsel in the course of interpreting guidance
Review/prepare for investor and agency audits
Assist with VA and State audits as needed
Review new investor information, as needed
Ensure that plan, policies and procedures comply with regulatory, investor and agency requirements and are incorporated into daily operating procedures. Be familiar with and coordinate the implementation of changes to policies and procedures as required by new or amended regulations

Grandbridge Agency Quality Control Compliance Specialist Resume Examples & Samples

Decide upon appropriate vendor qualification documentation and ensure that necessary information is maintained in specified files for all vendors (appraisal, engineering and environmental). Manage approved list of vendors (e.g. contact information, current insurance). Maintain an understanding of Fannie Mae and Freddie Mac third-party vendor requirements and keep the underwriting team, as well as the Bank, informed on those evolving criteria. Create and implement updates to the vendor engagement letters, as needed. Develop an internal Grandbridge engineering and environmental engagement letter
With input from subject matter experts, decide upon appropriate third-party review checklists (appraisal, engineering and environmental) on Freddie Mac deals. Ensure that checklists are property utilized and that necessary information is placed in the qualification files for each of the third-party providers. Ensure that the resumes and licensing information for the vendors is worded appropriately and saved to the appropriate location within the qualification file
Monitor and document exceptions and significant exceptions to policy and procedures through coordination with underwriting staff and BB&T’s Commercial Credit Administration (CCA). Identify and accurately document all exceptions in Grandbridge’s proprietary IMS system at the time that a deal closes. Prepare a report quarterly for CCA that details all significant exceptions on Fannie Mae and Freddie Mac transactions
Assist Grandbridge Deputy Chief Underwriting and Agency team with maintaining the Mortgage-Backed Securities (MBS) trade tracking spreadsheet and the approved list of MBS investors. Verify all trades are within the counterparty risk tolerance established for each counterparty and note any exceptions
Review narratives and CCA presentation for accuracy and any inconsistencies, engaging origination and underwriting teams to make necessary corrections and develop systematic measures to reduce the occurrence of such errors. Develop metrics to score and monitor team and individual performance over time
Collaborate with Grandbridge Risk Management team to establish, enforce and monitor processes and procedures to be established pursuant to BB&T’s requirements with respect to Bank Secrecy Act/Anti-Money Laundering (BSA/AML) requirements
Assist Grandbridge Analysts with various tasks from time to time, including the loading of documentation into Grandbridge’s DMS and Docstore systems, which can be a time consuming task when deal flow is high
Based on perspective gained through the above tasks, decide on priorities for risk mitigation and work with the Director of Agency Production to address those risks in the agency underwriting, approval and delivery process
Bachelor's degree in Business, Finance, Real Estate or related field, or equivalent education and related training
Five years of experience in multifamily lending as analyst with a strong preference for demonstrated knowledge and experience in specialized programs, such as Fannie Mae Delegated Underwriting and Servicing (DUS) and Freddie Mac Program Plus
Demonstrated strong experience with compliance, documentation and vendor management with multifamily deals
Ability to read, analyze and interpret complex documents and financial statements
Consistently exercise prudent judgment related to credit analysis
Possess the maturity and self-confidence to simultaneously handle a variety of assignments
Work harmoniously with internal and external associates, senior management and vendors
Productively assert authority over seasoned real estate professionals to influence behavior in achieving a high standard of regulatory compliance and work quality
Master’s of Business Administration degree in Finance or Real Estate
Eight years of experience in multifamily lending as analyst with a strong preference for demonstrated knowledge and experience in specialized programs, such as Fannie Mae DUS and Freddie Mac Program Plus
Underwriting experience in a commercial real estate environment
Effective management of lender/borrower relationship

Quality Assurance Compliance Specialist Resume Examples & Samples

Monitor, upgrade and document ongoing HACCP and allergen programs
Assist QA Manager with records maintenance and storage relating to Product Recall Program
Evaluate and develop processes and quality systems with Moonachie Terra plant to assure compliance with specifications
Work with QA Lab Technicians in maintaining/calibrating testing equipment throughout the Moonachie plant in order to ensure accurate data
Develop/maintain/update QA Lab Methodology
Work actively with Moonachie supervisors and managers to increase our ability to be proactive and decrease problems during production
Assist in training of Moonachie personnel in Quality and safe food standards
Work closely with Moonachie plant to assure continued improvement of quality through communication and review of product compliance to specification
Work with R&D during new product development and Production/Maintenance during new equipment shake down to assure adequate specification development
Bachelor’s Degree in food sciences, food process engineering or appropriate biological sciences
5 to 10 years work-related experience in food product development or quality control
Exceptional communication, creative, analytical and leadership skills
Bilingual - English/Spanish required

Compliance / Quality Specialist Resume Examples & Samples

Provides oversight of Cerner Quality System components (e.g. CAPA, Document Control, Complaint Handling, Objectives and Measures, etc.)
Authors and reviews quality communications (e.g., policies, procedures, and training) and makes recommendations for updates and edits
Disseminates CQS communications to individuals, groups, and/or company-wide
Guides continuous improvement activities across the organization
Analyzes CQS policies, processes, and procedures for the purpose of improving CQS participation and strengthening the CQS culture across all corporate levels
Applies CQS requirements to an organization’s specific business model
Facilitates change through the use of CQS projects, status meetings, and quality measures
Measures efficiency and suitability of CQS by tracking a group’s defined quality metrics and then performing trend analysis on the data
Defines and develops agendas for quality-related meetings and participates as necessary
Mentors and consults with others on CQS activities and processes
Monitors and reviews the group’s team-level processes to ensure efficiency, effectiveness, and consistent compliance
Keeps abreast of changes to significant regulatory and applicable agency’s standards through communication with Regulatory Affairs and other external agencies
Prepares for and participates in Internal and External audits
Works with appropriate resources to ensure that all action items resulting from Internal and External audits are resolved
Facilitates the Complaint Handling process, including but not limited to CHIAs
Proactively supports quality initiatives, corrective and preventative actions, and quality measures by ensuring timely updates and escalating concerns and/or non-compliances
Facilitates group risk assessment activities and identifies any quality-related process improvement opportunities
Communicates and works with all levels of management
Acts as a CQS liaison to Cerner’s Regulatory Affairs/Quality Assurance group
Ability to manage multiple projects and deadlines
Strong analytic skills and ability to work in a team and collaborative environment
Bachelor's Degree (or the equivalent), preferably in a related discipline
Prolonged use of a computer
Must live in, or relocate to, Kansas City

Quality Specialist Industry Standards Compliance Resume Examples & Samples

Resolves complex technical and regulatory issues in the plant with support from regional team
Requires cross-functional interaction and relationship with Manufacturing, Sourcing, Technology, EHS
Responsible for compliance and implementation of chemical management programs
Manage product and raw material regulatory and master data in Phoenix/Medusa and SAP QM databases and insure integrity and security of the data is maintained
Resolve product quality incidents from customer complaints, manufacturing problems, and field incidents using root cause and corrective actions
Be integral part of product commercialisation of new products in the NPI process starting at toll gate 3
Use QMS effectively and use the QTS process in resolving chronic product quality problems, reducing scrap, and reducing the cost of quality
Assure EHS compliance with chemical and equipment control regulations including but not limited to health and safety assessments, transportation, labelling, potable, food contact, internal auditing of all product regulatory and other requirements, regulatory assessment of proposed product changes, perform hazard assessments for MSDS development, author MSDS and product label content
Respond to external, and internal (GE Corporate) requests for product regulatory information, support customers with product regulatory issues, and interact with governmental and non-governmental agencies on product registrations / certifications
Process all Support Central workflows in Product Questionnaires [PQ’s], New Raw Material Introductions, Sub/Alts, and all MMOC to meet the assigned cycle time targets
Maintain a thorough knowledge of emerging regulations as they apply to products
Submit required reports and communications with regulatory agencies
Support Variable Cost Productivity [VCP] and Direct Material Productivity [DMP] projects in execution
Influencing: The ability to influence is a high priority competency requirement to all internal partners/external customers will be fundamental to achieving success
Business Focus: As a member of the SCPC team, you must understand the importance of meeting all performance & KPI targets and understand the direction of the global, regional GE Water strategy
Leadership & Teambuilding: As you are also part of a wider APAC team, you will need to be a “team player” in terms of sharing best practice and being prepared to cover for, and assist, other SC Team Members as required
Decision Making: You will make and be actively involved in frequent decision making over cost out initiatives and determining the appropriate support required to assist the GE Power & Water growth imperatives
Communication: You will need to have highly developed communication skills to communicate with all levels of the organisation; Participate in team meetings and participate in a positive, results-oriented work environment that is focused on EHS, quality, on-time delivery and continuous improvement
Job Specific Knowledge: You will have a good understanding of the water business, and develop the appropriate strategy and will conduct yourself in accordance with the GE’s Beliefs, EHS policies & Spirit and Letter obligations at all times

Compliance / Quality Specialist Resume Examples & Samples

Provides oversight of Cerner Quality System components (e.g. CAPA, Document Control, CHIA, Objectives and Measures, etc.)
Authors, edits, and reviews quality communications (e.g., policies, procedures, and training) and makes recommendations for updates
Disseminates CQS communications to individuals, groups, and company-wide as necessary
Has the knowledge to perform document control functions
Guides Quality Improvement activity across the organization
Leads organizations in the development and implementation of measureable Quality Plan objectives and results
Analyzes CQS policies for the purpose of improving CQS participation and strengthening the CQS culture across all corporate levels
Defines and develops agendas for quality-related meetings and leads or participates as necessary
Proactively monitors attendance for corporate/required training courses and provides any additional training resources needed
Mentors and consults on Cerner Quality System activities and processes
Monitors and audits the group’s team-level processes to ensure consistent compliance
Keep up-to-date on changes to significant regulatory and applicable agency’s standards through communication with Regulatory Affairs and other external agencies, as applicable to the associate’s domain
Works with appropriate resources to ensure that all action items pending from internal and external audits and Management Review Meeting are resolved
Facilitates the Complaint Handling (CHIA) process as applicable
Facilitates client notifications regarding complaints (CHIAs) as situations merit
Monitors and performs trending on root cause analysis activities within assigned group and participates as needed
Identifies and provides closed loop feedback on process improvement opportunities by resolution of complaints, or by analysis of quality metric or process review trends for the group
Identifies CAPA items and oversees documentation of, and response to, CAPA items for the group
Escalates and works with senior management on resolutions to overdue quality items or any negative trends identified
Acts as liaison to RA/QA for group
Proactively supports the quality initiatives, corrective and preventative actions, and quality measures by ensuring timely updates and escalating concerns and non-compliances
Performs other responsibilities as needed
Works in accordance with corporate and organizational security policies and procedures. Understands personal role in safeguarding corporate and client assets. Takes appropriate action to prevent and report any compromises of security within scope of role
Bachelor’s degree or equivalent related experience
6-12 years business experience
Background in computer usage and computer technology
Previous regulatory and/or quality assurance experience/exposure
Healthcare related experience preferred
Strong grammar, usage, proofreading and editing skills
Ability to clearly present information, both orally and in writing

Quality Assurance Compliance Specialist Resume Examples & Samples

Support and facilitate corporate or T&D compliance and quality management initiatives includes Sarbanes-Oxley (SOX) Compliance quarterly certification, corrective action plan tracking program, Approval Authorization Matrix (AAM) review, critical business records (CBR) initiative, or QA Change Management review, etc
Provide advice and consulting on related quality matters. Meet with internal clients to review findings which include issues and recommendations for Senior Management; assists control owners, technical subject matter experts, compliance managers, and program managers ensuring corrective action plans and controls are designed to remediate identified gaps and risks
Demonstrate skills in control rationalization and improving efficiency and effectiveness of internal controls process design through effective collaboration and interaction with program or process owners
Prepare presentations and reports on quality assessment results to key stakeholders or owners of the process/compliance requirements
Perform all tasks in a safe manner in compliance with company safety policies and according to applicable regulations
Four or more years of experience in audits, assisting in the development of quality assurance programs, performing QA assessments and compliance reviews
Two or more years of experience using statistical methods to identify trends and advanced data analytics or modeling to drive compliance and detect abnormalities and evolving risks
Two or more years working with legal and regulatory requirements
Bachelor’s degree or master degree in engineering, project management, business, finance or a related discipline
Experience working collaboratively with operations staff to drive quality improvements and deliver necessary compliance requirements while maintaining a collaborative environment between functional areas
Knowledge of industry best practices and standards in the field of risk management, compliance, and/or quality assurance
Experience working in CA regulated utility/Transmission and Distribution (T&D) environment and applying regulatory and legislative compliance for utilities (FERC, NERC, CPUC, etc.) and financial reporting (SOX)
Certificate and/or Licenses: Industry certification in auditing: CIA or CPA; or in other related quality management professional certification: CMQ, CISA, CQA, CISSP, CISM, CSQE, CGEIT, and/or CRISC

Compliance / Quality Specialist Resume Examples & Samples

Coordinate resources which may include people, data, and processes
Initiate and develop relationships with internal/external constituencies and provide support
Provides service and support to the regulatory program
Ensure process documentation is clear, relevant, and meets regulatory requirements
Ensure timely updates to escalate concerns and non-compliances
Facilitate formal continual improvement processes
Provide audit support for regulatory programs and other external audits
Bachelor’s Degree or equivalent
At least 1 year of IT or Health Care work experience
At least 1 year of Compliance and/or Regulatory work experience

Compliance / Quality Specialist Resume Examples & Samples

Knowledge of healthcare industry and billing/reimbursement practices
Previous regulatory, compliance and/or quality assurance experience
Ability to work on multiple projects simultaneously and prioritize work to meet adapting deadlines
1+ year of previous regulatory and/or quality assurance experience
1+ year of Healthcare experience
1+ years of auditing experience
CHC, CPC, RHIT Certifications

Quality Assurance & Compliance Specialist Resume Examples & Samples

Performs phone quality reviews; monitors inbound and/or outbound calls to analyze and evaluate customer service skills against established phone quality metrics, including but not limited, to call process measurements, accuracy of information provided, tone of employee, effective call management, and demonstrated professionalism using a proprietary Call Scorecard System
Documents quality issues and performance measures for management review; analyzes results and recurring trends; provides feedback to management concerning these findings
Provides feedback to offer positive reinforcement and drive continuous improvement
Demonstrates, advocates, and reinforces a positive team environment, professionalism, and the need to present a positive image of the company when interacting with customers
Participate in and facilitate calibrations providing feedback in a concise and constructive manner
Complete quality projects designed to measure business compliance with certain regulatory requirements as needed
2-3 years customer support experience in a high volume contact center with 1+ years of experience in a quality assurance role
Working knowledge with Microsoft Office Applications (Outlook, Excel, Word, and Internet Explorer)
Motivated self-starter with solid organizational skills, strong listening, verbal, and written skills
Ability to abstract information from multiple sources and input detailed, accurate information
Passion for working in a fast-paced environment, with the ability to adapt quickly to change
An exemplary work ethic, a “get it done” attitude and high personal accountability
Self-motivated critical thinker with the ability to work independently
Strong organizational and prioritization skills, with a proven ability to manage multiple projects and deadlines effectively
Ability to maintain objectivity and lack bias in evaluations
Proven ability to exceed customer service standards

Quality Specialist, Systems & Compliance Resume Examples & Samples

Review incursions into classified areas for process and environmental impact and approve accordingly
Conduct periodic shop floor audits to ensure cGMP compliance
Ensure proper control of materials via product investigations
Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
Minimum 3 -7 years’ experience in pharmaceutical operations, technical services, and/or quality operations with at least 2 years in a quality function or targeted training in quality to perform the defined responsibilities
Experienced in the methods and approaches of conducting environmental monitoring
Experienced in the methods and approaches of conducting quality audits

Quality Assurance Compliance Specialist Resume Examples & Samples

Responsible for the handling of change requests from the departments, such as Master Batch Records (MBRs), Specifications (SPECs), General Changes (GENs), etc
Also process art work changes, such as changes on texts or layouts and ensure, that parts lists will be correctly handeled and changes has been implemented
Create internal reports
Response on internal and external requests, such as compliance issues, registration queries and regularizations
Develop, check or revise pharmaceutical Quality Agreements; for example compare contests with standard operating procedures or other internal Regulation
Prepare on time yearly Product Quality Reviews
Create proposals for customers and take care of financial management
Revise or create standard operating procedures on work stations and/or improve their systems and provide trainings

Compliance / Quality Specialist Resume Examples & Samples

Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements
Leads and participates directly in the investigation process
Writes and/or reviews investigation reports
Ensures Corrective & Preventative Actions are appropriate, are implemented as planned, and have the intended effectiveness
Identifies recurring events and ensures appropriate actions are taken, such as Management notification
Keeps team members informed of the status of assigned work
Leads and manages Change Controls for External Manufacturing
Works with the team to develop robust training programs
BS in chemistry, biology or related field with 3– 5 years experience in leading investigations/change controls in a cGMP environment. Will consider Bachelor’s degree in other discipline with relevant experience
Must have detailed knowledge of industry best practice and current regulatory expectations concerning sterile drug product or medical device manufacturing
Must have direct experience performing review of Manufacturing/Validation/Quality documentation in cGMP biopharmaceutical /drug substance or aseptic processing
Experience working with contract manufacturing organisations an advantage
Proficiency in French or German would be an advantage
Risk assessment and risk management experience an advantage
Ability to prioritize, monitor and report on daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment

Quality Assurance Compliance Specialist Resume Examples & Samples

Stay abreast of all bank, regulatory and state requirements. Identify new requirements or rules that require changes within Consumer Lending and test for accurate adherence to the new requirements. Ensure all policies and procedures are followed. Provide management reporting
Review underwriting of certain loan types, focused on HELOC and complex transactions
Provide recommendations on appropriate course of action related to their findings. Inform management of audit findings, trends and concerns through monthly management reports
Research relevant requirements and changes as they relate to the entire Consumer Lending operation. Route to appropriate Business Unit Managers and test compliance. May direct training on specific changes as needed
Fully versed on all compliance regulations as related to Consumer Lending functions. Monitors for compliance related changes and disburses information to pertinent business unit
Aid in complying with appropriate bank, regulatory, and state specific document and servicing requirements
Respond to requests of other departments in a timely manner
Occasionally assume additional duties as assigned including: back-up coverage and other assistance as needed
Minimum 3 years of experience in Consumer/Mortgage Lending, Real Estate, or equivalent industry. Experience in Consumer Loan Processing, Servicing, or Underwriting preferred
Consumer Loan servicing experience will be given particular priority, especially previous experience with LaserPro, DecisionPro or Mortgage Servicing Platform (MSP) software
Must be a proven self-starter, dependable, accurate in completing responsibilities with strong attention to detail and organizational skills
Excellent communications skills: phone, personal contact/verbal and written
Strong desire and ability to work with employees and customers in a co-operative, professional and friendly manner. Able to work as a part of a team and with people of diverse backgrounds. Proven ability to work with a variety of personality types in diverse situations, at all times maintaining a professional demeanor
Ability to work independently, set priorities and handle multiple tasks
Must exercise good judgment, accept responsibility and handle confidential information
Strong abilities in problem solving, researching and decision-making
Willingness to assume additional duties/projects as required
Able to accept and facilitate change
Ability to learn quickly is not afraid to ask questions and take instruction constructively
Able to work within tight deadlines and under extreme pressure
Keyboarding skills and proficiency in Word/Excel/Outlook and the internet with ability to learn new software applications
Regular and punctual attendance required. Must be able to work overtime as needed
This position requires operation of a PC and viewing information on a PC monitor. Must be able to sit for many hours each day. Must be able to communicate via telephone and possess dexterity to include filing, reaching and bending