Specialist Quality Assurance Resume Samples

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R Hahn

Reinhold

Hahn

11035 Turner Corners

Boston

+1 (555) 162 1332

11035 Turner Corners

Boston

Phone

p +1 (555) 162 1332

Experience Experience

New York, NY

Specialist Quality Assurance

New York, NY

Dooley, Stokes and Shields

New York, NY

Specialist Quality Assurance

Participate in drafting, negotiating and maintaining quality agreements with different suppliers and or clients of Sanofi Canada
Approve artwork for printed packaging components used for packaging and labeling of products
Participate in global Quality initiatives ensuring that ABR input is provided and leading ABR implementation activities
Operating and Manufacturing Procedures
Participate in new product launches and special projects, support marketing and business development groups
Interpret and execute policies/procedures and lead validation engineers on an ongoing project basis
Quality review and approve Validation Documents including: DT, CRSIQ/OQ, RTM, FT/FTF, protocols, reports, etc

Chicago, IL

Specialist, Quality Assurance Analyst

Chicago, IL

Schinner LLC

Chicago, IL

Specialist, Quality Assurance Analyst

Perform various quality audits and lead/assist with research initiatives
Listen to recorded telephone conversations between mortgage loan customers and Customer Service Representatives/SPOC Case Managers/Collections Representatives
Identify causes for QA/QC defects and collaborate with business leaders to develop solutions
Provide feedback to employees regarding QA/QC results
Implement process and reporting that are developed to ensure compliance with internal, investor and regulatory guidelines
Support training for Special Loans/ARMs employees regarding procedural changes and process updates
Analyze letters being sent to customers in the loss mitigation process, identify and record deficiencies

present

Detroit, MI

Specialist, Quality Assurance Compliance

Detroit, MI

Klocko, Pacocha and Bahringer

present

Detroit, MI

Specialist, Quality Assurance Compliance

present

Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry manufacturing site
Provides response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review
Performs QA oversight of assigned contract manufacturing / testing partners as assigned
Generates annual product reports for products made on Boudry manufacturing site
Supports the deployment and execution of GMP training intended for all Boudry manufacturing site departments involving GMP activities
Supports internal audits plan by executing self inspections and following-up on action plans
Can be assigned “ownership” of QA Compliance processes, including coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training of new users

Education Education

Bachelor’s Degree in Computer Science

Northern Illinois University

Bachelor’s Degree in Computer Science

Skills Skills

Possesses a strong, detailed knowledge of site's manufacturing processes and procedures
Drives and maintains a strong QA training program
Possesses proficiency in reviewing and approving deviations, change controls, work orders, protocols, reports, batch records, and other GMP documents
Performs other tasks as assigned
Stay up to date with all training materials/activities
Participate in cross-functional training to support fellow team members
Solicit training internally and externally, as necessary
Helps ensure QA group is consistent in making decisions by fostering constant team communication
Maintains efficient and effective QA procedures
Serves as the chief QA point of contact for any assigned projects/initiatives

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Specialist Quality Assurance Resume Examples & Samples

Develop overall quality tactics and strategies to resolve the root causes of problems and develop detailed work plans to manage on customer experience and quality
Collaborate with all Quality Assurance leaders across Montreal, Toronto and Vancouver
Write summaries of all analysis and actions required for senior management
Act as point of contact designated in terms of results, strategy and action plan for quality of service
Engage and advise internal/external partners and suppliers across Canada & overseas in terms of quality assurance
Work closely with the Loyalty management teams to analyze the results in terms of quality, make predictions about the performance and follow through action plans
Develop strong relationships with managers at various levels within the Loyalty organisation and liaise regularly with senior management team to consolidate the results in terms of quality

Lead Ops Specialist, Quality Assurance Resume Examples & Samples

Assist with meeting accuracy and productivity goals by supporting staff with complex issues and tasks
Serve as a processing resource during high volume periods and to ensure the proper application of regulatory guidelines
Assist with improving departmental policies and procedures by questioning the effectiveness of existing processes, identifying potential risks and making recommendations for improvements
Ensure the team meets business goals by effectively managing workflows and ensuring service requests and tasks are handled within department SLA
Provide coaching and feedback to team members to build departmental business acumen and resolve processing discrepancies
Serve as a primary contact for handling questions, escalations and complex research items
Create and update procedural documentation and provide support for audit and risk management initiatives
Assist with the accurate completion of monthly productivity reporting
Successfully lead and organize team meetings and Knowledge Share Sessions
Assist with projects and system enhancements as instructed by management
Superior skills with Microsoft Excel, Access and PowerPoint
Excellent problem solving, oral and written communication skills
Demonstrate proficiency in supporting business process improvements
Team player, able to collaborate with peers, management and business partners
Flexible and willing to work additional hours to accommodate business needs
Able to prioritize and organize work to meet strict deadlines in a fast-paced environment
Highly self-motivated with the ability to perform complicated tasks with minimal supervision
Knowledge of Commissions, Billing, LPL reporting and/or technology products
Oracle, Documentum, Siebel and BETA experience preferred
Must obtain FINRA Series 99 license within 90 days of hire
3+ years of financial services experience preferred
College Degree or equivalent experience

Specialist Quality Assurance & Operations Resume Examples & Samples

QA Support: Work with Engineering, Product Development, Food Science, Facilities and Pilot Plant Operations personnel to ensure that all projects and activities are performed in a manner that meet and support all Federal standards for Good Manufacturing Practices, HACCP and Food Safety Modernization Act. Establish and ensure that policies and procedures specific to the Pilot Plant are appropriate and aligned with relevant corporate PEP standards. Provide support during Pilot Plant product runs for consumer testing and sales samples. Work with Quality & Regulatory Compliance to ensure that food safety issues are properly communicated to all Tech Center Residents as appropriate. Maintain alignment with QRC on food safety risks associated with new ingredients and implement plans to control risk in the pilot plant. Maintain the necessary documentation and records related to quality assurance and sanitation policies, programs and procedures, including food safety plans and process preventive controls for established pilot scale production lines. Provide technical support to ware washing function as needed to support quality of services provided to Microbiology, Analytical, Product Development, and Food Science Lab operations
Cleaning Support: Work with Building Sanitarian to develop and maintain cleaning procedures for Pilot Plant processing equipment to ensure sanitary conditions and prevent infestation issues. Provide technical support to ensure that janitorial contractors are adhering to the cleaning specifications and cleaning frequencies are appropriate for the building areas. Train equipment users in proper cleaning procedures, cleaning solutions and storage practices. Work with users, technical staff and equipment suppliers to verify new and existing equipment meets relevant sanitary design standards to facilitate cleaning efforts. As required, ensure that all process equipment shipped from the Tech Center meets sanitation, allergen and kosherization standards. Ensure that maintenance chemicals and cleaning solutions used in the building are appropriate for particular application and are properly handled
Training: Create and implement training programs and informational materials as required to convey the above policies and procedures to Technical Center residents. Create and implement additional training programs that arise as food laws change and new issues surface in the food industry. Maintain an effective New Employee Orientation program. Conduct new employee orientation sessions on GMPs, Pest Control, Allergens, and all other policies and procedures that apply to work conducted in the Pilot Plant
Auditing Conduct periodic audits of the Pilot Plant, Restroom and Laboratory areas to ensure that cleaning and pest control procedures and specifications are being followed and met. Conduct periodic Pilot Plant walk-through of all areas with Pilot Plant members using established checklists for evaluations. Report on the results, corrective actions and effectiveness of these activities
Ability to effectively plan and execute multiple priorities while being flexible and adaptive to change
Ability to effectively work with Product Development and Engineering to understand new product innovation, ingredients and processes
Superior communication skills in verbal and written forms
In depth understanding of a production / manufacturing environment
Demonstrated knowledge and implementation of Sanitation Principles to food processing equipment and environments including Pest Control Principles
Advanced problem solving/trouble shooting skills
Detailed knowledge of regulatory and quality system requirements – PEP, HACCP, Good Manufacturing Practices (cGMP), GFSI/SQF Standards, Food Safety Modernization Act and Preventive Controls, etc
Proficiency in computer programs / software such as Microsoft Word, Outlook, Excel, Access, Power Point, SAP, Database Systems, etc

Lead Specialist, Quality Assurance Resume Examples & Samples

Work within the QA/QC team to successfully deliver the programme to the required quality standards
Support the development, implementation and monitoring of the programme quality plan
Support all Consultants, Design Consultants and Design, Construction Supervision Consultants and contractors in the implementation of Quality, Plans and procedures and the monitoring of their performance on all Quality matters
Execute audits, including unannounced visits, and follow up with reporting and advice on necessary corrective actions
Prepare statistical reports on Quality performance
Identify and communicate lessons learned though the programme lifecycle
Minimum of 7 years of experience in related projects
5 years + of site based construction experience
Experienced in compliance to ISO 9001, 14001 and 18001
Undergraduate degree
Relevant QA qualification
Report writing and communication skills
User of MS Office
Preferably previous experience of projects in the Middle East

ADT Specialist, Quality Assurance Resume Examples & Samples

Responsible for the Quality support functions associated with the manufacturing of products
Draft, review and approve technical documents such as procedures or master batch records
Ensures that products are manufactured, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPs
Participates in the development and maintenance of QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
Train, coach and/or mentor others on technical, personal development or business issues
Assists in data compilation of annual product review
Responsible for QA advisement for project outcome and customer interaction
Participates in the development and implementation of process related improvements
Assist with manufacturing floor activities (equipment/room approval, facility compliance)
Bachelor’s Degree with 3+ years of experience in pharmaceutical industry is required
Quality Assurance experience, preferred
Laboratory experience, preferred
Receives and provides instruction, guidance and direction from/to others
Based on broad technical skills and QA experience, anticipates and identifies unmet customer needs
Proactive to address work issues at the individual and team level
Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form
Excellent written and verbal communications skills with internal and external customers, peers and managers
Recognizes unmet needs within department and business

Specialist, Quality Assurance Compliance Resume Examples & Samples

Supports internal audits plan by executing self inspections and following-up on action plans
Supports the supplier qualification process by assisting in material supplier and vendor evaluation and approval. The position holder may participate in external audits as Celgene audit team member, QA liaison or subject matter expert (SME). Provides support for vendor and supplier contract setup and modification, as needed. Is responsible to handle deviations, CAPA and change controls related to suppliers
Generates annual product reports for products made on Boudry manufacturing site
Supports preparation and execution of authorities inspections and corporate audits in different roles (i.e. back office, subject matter expert, note taker or runner)
Performs QA oversight of assigned contract manufacturing / testing partners as assigned
Informs on regulatory changes and coordinate assessment and action plans with SMEs
Provides response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review
Supports the deployment and execution of GMP training intended for all Boudry manufacturing site departments involving GMP activities
Contributes of regular reporting of quality processes metrics for different review meetings
Ensures the representation of QA within department and cross-functional project teams according to assignments
Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry manufacturing site
Acts as deputy for colleagues within QA Compliance team
Can be assigned “ownership” of QA Compliance processes, including coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training of new users
At least 3 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance
BS in Science or related field
Very good understanding of cGMPs and regulatory requirements
Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred
Excellent interpersonal, collaborative and organizational skills
Works independently on routine tasks, makes decisions for minor issues
Ability to focus attention to details
Very good written & oral communication skills
Very good investigational and QA problem solving skills
MONEU

Associate Specialist, Quality Assurance Resume Examples & Samples

Responsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, procedures, test plans and summary reports. This responsibility includes IQ/OQ/PQ and method validation approvals. Responsible for QA review and approval of change control requests (e.g., DCRs, CCRs) to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable
Performs QA review of change controls
Provides QA support for all facility departments. Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensures they are resolved in a compliant manner with the coaching and support of senior members of the QA team
Responsible for QA review and approval of deviation investigations
Responsible for reviewing and approving materials for use in commercial production
Provides QA support for site projects including initiatives to expand into new product markets
Completes product inspections and reviews to help ensure product quality and patient safety
Responsible for QA review and release of in-process and finished product
Performs other duties as necessary to ensure the efficient and effective operation of the department
An Associate’s degree in a technical field is preferred
Demonstrated knowledge of aseptic pharmaceutical manufacturing is preferred

Specialist, Quality Assurance Esystems Resume Examples & Samples

The position holder will perform the review and approval of master data for the PTM process within the Oracle EBS System
The position holder is responsible to work with the local and global PTM Oracle MDM teams to maintain improve the procedures and processes related to Oracle EBS MDM
Supports the deviation handling system by handling deviation and executions investigations within the QA eSystem area of responsibility
Represents QA eSystems within project teams according to assignments and can handle validation documentation QA review as required for IT systems for Celgene International
Writes and assists with writing of SOPs, WPs etc for QA eSystems
The position holder will participate as required in project teams for changes and improvements in the Oracle EBS application
The position holder will participate as required in testing of changes made to the Oracle EBS application
As directed and required, the position holder will organize cGMP compliant system management and user trainings
Supports the Manager, QA eSystems, the Director QA Operations and the QA Compliance groups with investigations, root cause analyses and CAPA definition as needed and appropriate
Acts as deputy for the Manager QA eSystems (assigned tasks and responsibilities)
At least 3 years of experience within Quality Assurance and/or Quality Control in a pharmaceutical company or other related industry, with experience with IT systems
BSc/BA (or equivalent) in Life Sciences, IT or a related discipline
Good understanding of cGMPs and FDA regulatory requirements
Ability to understand, review and approve Oracle EBS MDM
Knowledge of Oracle EBS an advantage
Knowledge of most common office software (Microsoft Office)
Sense of responsibility, reliability

Associate Specialist, Quality Assurance Resume Examples & Samples

Drives and maintains a strong QA training program
Participate in cross-functional training to support fellow team members
Stay up to date with all training materials/activities
Solicit training internally and externally, as necessary
Possesses proficiency in reviewing and approving deviations, change controls, work orders, protocols, reports, batch records, and other GMP documents
Possesses a strong, detailed knowledge of site's manufacturing processes and procedures
Performs other tasks as assigned
Helps ensure QA group is consistent in making decisions by fostering constant team communication
Maintains efficient and effective QA procedures
Serves as the chief QA point of contact for any assigned projects/initiatives
HS diploma or equivalent. Associate’s degree in a technical field preferred
An equivalent combination of education, experience, and training may substitute
Must have basic GMP, OSHA, DEA, USP, EP and Quality knowledge
Must be able to properly communicate routine business matters with management with a high level of accuracy
Must have a high degree of computer skills to increase the department's productivity, including proficiency in Microsoft Office
Must be able to interact appropriately with regulatory agencies
Must have ability to multi-task, manage time effectively, and have strong organizational skills
Must have basic scientific knowledge
Must demonstrate basic writing skills and be able to follow technical reports
Must be action-oriented, customer-focused, and possess learning agility
Must be able to learn from mistakes and actively listen
Must possess strong critical reasoning skills and demonstrate the ability to solve routine problems

Specialist, Quality Assurance Analyst Resume Examples & Samples

Previous Special Loans/ARMs experience preferred
Rapidly adapts to changing information, conditions and/or unexpected obstacles
Proficient with Microsoft Office products (e.g. Word, Excel, Outlook, Access, Powerpoint, etc.)

Principal Specialist, Quality Assurance Resume Examples & Samples

Responsible for maintaining quality standard of products and the procedures and materials that go into work scope. Aligns quality management function with the performance needs of product lines
Provides specialized technical expertise in support of the Quality program, including specialized inspection and testing techniques, quality training, statistical methods, audits, quality tools for problem solving and assessment
Creates inspection reports stating the conditions of a work area to ensure requirements are met. Makes recommendations for corrective action
Applies knowledge of quality systems and tools to validate and verify contractually required standards for project execution
Implements principles of performance evaluation and prediction methods are used to improve product systems safety, reliability, and maintainability
Work with project teams, clients and Inspectors to provide inspection planning and management under regular supervision
Schedule and lead QA-focused team meetings to create and implement plans

Specialist Quality Assurance Resume Examples & Samples

Applies basic concepts, principles, and technical capabilities to perform routine tasks
Follows established procedures to resolve readily identifiable technical problems
Works under direct supervision and receives detailed instructions
Develops competence by performing structured work assignments

Associate Specialist Quality Assurance Resume Examples & Samples

Review and approve Standard Operating Procedures (SOP) ensuring SOP’s reflect accurate working practices, documents are logical and are technically sound
Raise and record Deviations for out of spec activity. Ensure they are presented at relevant meetings for grading. Investigate when level of deviations are above acceptable level and support production staff with investigation reports and approve
Raise CAPA’s ensuring they are appropriate and approve on closure
Assess Change Controls ensuring the right impact assessments are correct and appropriate
Perform formulation and blend checks to ensure they are within range for final product to minimise batch loss
Monitoring Ampules stock levels. Ordering of Ampules if levels are low. Process and deliver to client
Drive and provide septic training for production staff to continuously improve the levels of sterility within the environment
Support and mentoring of QA staff supporting quality decisions and use of QA systems such as Track wise and Midas
To uphold company procedures in regards to GMP, Eudralex Vol.4, FCA CFR21 and VMD and comply with UK pharmaceutical and financial regulations at all times
To comply with company health and safety practices and procedures
Degree in a Science discipline
Good understanding of Manufacturing regulations
5 years Steriles QA expertise
Good understanding of GMP Quality Systems
Protocol and Report writing experience
Good Excel/Word skills

Associate Specialist Quality Assurance Systems Resume Examples & Samples

Management of Supplier Qualification, Review and update of Technical Quality Agreements, Management of Supplier Change Notifications
Change Control Management System performance review, linking supplier and material changes to the Change Control system
GMP training delivery
Supporting the Product Quality Review compilation and review
Typically a graduate, or equivalent, with experience of cGMP and working within a quality management systems environment
5 years’ experience within QA in the Pharma industry
Technical report writing and database management
Excellent interpersonal skills including good communication

Specialist Quality Assurance Call Centerus Resume Examples & Samples

Evaluate agents in conjunction with department policies, sales objectives, and service standards; will provide positive and constructive feedback to help consistently define expectations for call center employees
Verifies results by measuring skills, product knowledge, sales and service abilities, and efficiencies of calls
This position will be responsible for the preparation and maintenance of daily, weekly and monthly reports reflecting guest service standards and employee performance
Responsible for crafting and implementing creative and motivating contests and games to inspire a positive community within the department and encourage employees to always strive to be better by performing at the top of their abilities every day
Must be knowledgeable and supportive of all booking policies and procedures, company and Forbes service criteria, as well as department standards and expectations
Identifies training needs, assists in developing training programs, and conducts training classes with call center management teams
Directs quality initiatives by requiring adherence to quality assurance policies and procedures; develops new models and implements changes as needed
Responsible for maintaining the Wynn standards of service to guests and coworkers at all times
Able to multi-task and demonstrate the ability to coordinate, organize and prioritize several projects at once; Maintains calmness when under pressure
Excellent time management skills; able to meet deadlines
Look for opportunities to assist peers, guests, other departments or leaders at all times
Solution oriented, avoiding conflict and gossip, stays on task and promotes teamwork
Ensures the Wynn standards of cleanliness and appearance for all areas
Works with safety as a priority, and follows department and company safety standards
Knows and adheres to Wynn policies and procedures, embraces company culture and takes pride in the resort and amenities
Understands and well versed in the resort, hotel features and services including all outlets, hours of operation, activities and events available to guests
Attends required training classes and incorporates new knowledge gained into daily work practices
Contributes to team efforts and goals by assisting with related office tasks as needed

Specialist Quality Assurance Resume Examples & Samples

New product introductions (NPI)
Nonconformance
CAPA (Corrective Actions / Preventative Actions)
Operating and Manufacturing Procedures
Audit liaison and commitment tracking / closure
Project team participation and leadership
Product disposition
Equipment and System Validation

Specialist Quality Assurance Resume Examples & Samples

Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing
Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations
Ensures that changes that could potentially impact product quality are assessed according to procedures
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Alerts senior management of quality, compliance, supply and safety risks
Completes required assigned training to permit execution of required tasks

Specialist Quality Assurance Resume Examples & Samples

Collect, review and approve all required documentation necessary for product release, including batch documentation review
Process the change controls
Inspect and release products on Canadian market
Inspect products, review documentation and release Clinical Supply Materials products
Maintain specifications and methods up to date
Send product for testing, approve results and support laboratories if required
Issue, evaluate and approve Change Requests, Deviations and CAPAs
Evaluate Investigations and Annual Product Review
Prepare Annual Product Quality Reports (APQRs)
Process Product Technical Complaints for marketed and non-marketed products. Investigate issues, establish corrective action and reply to customers in timely manner
Request and review stability results
Approve artwork for printed packaging components used for packaging and labeling of products
Coordinate the preparation, review and issuance of SOPs and other technical documents
Participate in drafting, negotiating and maintaining quality agreements with different suppliers and or clients of Sanofi Canada
Contribute to the archiving system as per Good Documentation Practices (GDPs) and according to corporate and Canadian requirements
Participate in recall processes as required
Review and maintain Sanofi Canada Licenses
Tracking, requesting, and compilation and compliance status of GMP evidence from all foreign contractors to allow importation of products into Canada via valid Establishment License
Participate in the preparation of regulatory documentation needed for Health Canada submissions and notifications
Participate in new product launches and special projects, support marketing and business development groups
Participate in regulatory inspections (Health Canada) as well as corporate audits
Ensure auditor functions (internal/external as required)
Provide QA expertise to internal and external partners. Interface with 3rd party and foreign site organizations on GMP matters
Other QA duties as assigned
5 years of relevant experience in pharmaceutical industry (QA, QC, Production or equivalent)
Extensive Knowledge of Canadian GMPs
Specific skills and/or competencies Critical mind
Excellent analytical and problem solving abilities
Team players
Ability to maintain good interpersonal relationships
Ability to set priorities
Good Writing and communication skills (verbal and written)

Specialist Quality Assurance Resume Examples & Samples

Provide leadership and coordination of validation activities
Develop PPQ strategy for NPIs
Develop/Update Validation Master Plans
Ensure compliance to Part 11
Author validation sections for filings and /or provide data verification
Develop Validation protocols/reports
Quality review and approve Validation Documents including: DT, CRSIQ/OQ, RTM, FT/FTF, protocols, reports, etc
Develop and mentor junior staff
Champion Operational Excellence Projects
Ensure alignment with regulatory guidelines and industry standards
Review requirements and source documentation (MBRs, PDTs, PCSRs, SOPs, Specifications), for use in development of Validation documents
Provide guidance for the generation, resolution and closure of deviations
SOP development, review and approval Provide Change Control Assessments
NC/CAPA initiation/ownership
Generate/facilitate quality risk assessments for automation and equipment (QRAES)
Interpret and execute policies/procedures and lead validation engineers on an ongoing project basis
Coordination of activities between Amgen teams (Validation, Manufacturing, F&E, Automation, QC, etc.)
Master's Degree and 3 years of Quality experience OR
High school diploma/GED and 12 years of Quality experience
6 + years of experience in pharmaceutical or biopharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment
Technical understanding of pharmaceutical/biotechnology unit operations
Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports
Proven experience in multiple regulatory inspections
Knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes
Communication, presentation, organization, team development and leadership skills
Knowledge of risk-based validation methodologies, such as GAMP5, regulatory agency expectations, biopharmaceutical processes, project management, strategic resource management and business analysis
Ability to evaluate compliance issues and interact with regulatory inspectors
System knowledge and experience with EBR, Delta V, NC, CAPA and Change Control processes
Ability to manage multiple complex tasks at one time

VP-specialist, Quality Assurance / QA Testing Resume Examples & Samples

6-8 years of experience in a systems quality environment required, experience in the securities or financial services industry is a plus
Ability to execute UNIX shell scripts
Excellent written and verbal communication, interpersonal, and organizational skills
Expecience with Web Service testing
Test Automation Scripting using Selenium or QTP is a plus
CSTE Certified

Specialist Quality Assurance Resume Examples & Samples

Oversee supplier audits, ensure any improvements or corrective actions are addressed to Amgen’s satisfaction, negotiate quality agreements between Amgen and suppliers, oversight of all activities related to nonconformance investigations, customer complaints, CAPA records, change control records, supplier and material status within Amgen’s ERP system
Participate on a cross functional supplier management team with colleagues from Supply Chain, Process Development, Global Strategic Sourcing and other departments to assess, communicate, and manage supplier performance via scorecards and business meetings and shape the business strategies pertinent to the supplier and/or materials they provide
Lead continuous improvement activities in partnership with the supplier to eliminate waste and achieve standards of operational excellence for Amgen and the supplier
Work in a team matrix environment and independently interact with various levels of management to drive items to resolution; serve as a liaison between Supplier Quality and key stakeholders
Set commitments, be accountable and seek opportunities for continuous improvement and exercise independent judgment
Articulate and educate others on the supplier manufacturing processes, the end-to-end use of materials in Amgen products and regulatory/compendia requirements, and Amgen’s SQM business processes, identify process gaps and introduce innovative solutions. Lead operational excellence projects to improve efficiency and, productivity, while decreasing expense/operating costs
Doctorate degree OR
Experience with single use systems/assemblies, filters, sterile components
General knowledge of cGMP regulations, practices, and trends pertaining to Supplier Management and monitoring
Project management skills and the ability to handle multiple projects simultaneously
Understanding of biopharmaceutical bulk, drug product manufacturing and distribution processes
Ability to evaluate compliance issues and to work in a fast paced environment with ever changing priorities

Specialist Quality Assurance Resume Examples & Samples

Provide direct Quality Assurance support for all GMP activities (including on-the-floor quality oversight, raw materials release, nonconformances, change control and CAPAs) at ARI
Support routine GMP documentation review activities (e.g. SOPs, logbooks, etc.) and ensure key performance indicator meet targeted metrics
Act as one of the key Quality Contacts to resolve complex issues, adhering to Amgen policies and standards
Participate in root cause investigations for complex and significant nonconformances, leveraging various root cause analysis tools
Participate in regulatory inspections, and interact directly with regulatory inspectors
Lead and support site/network driven QA continuous improvement initiatives/activities
6 Years of experience in pharmaceutical or biopharmaceutical environment with cGMP FDA regulated operations/engineering/manufacturing/quality environment
Direct Raw Material or Plant Quality Assurance experience with pharmaceutical or biopharmaceutical processes
Proven experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Raw Material Disposition and/or Plant Quality Assurance in the pharmaceutical or biopharmaceutical processes
System knowledge and experience with SAP, LIMS, NC, CAPA and Change Control processes
Strong skills in communication, presentation, organization, team development and leadership

Solution Specialist Quality Assurance Resume Examples & Samples

Adapting to new technologies and gain a functional understanding
Bachelor's degree, preferably in Computer Science, Information Technology, Computer Engineering, or related IT discipline; or equivalent experience
Understand Software Development Lifecycle and Enterprise Value Delivery Methodology for automation testing/deployment process
4-7 years of experience creating test plans, test cases from system requirements and/or user stories

Senior Solution Specialist Quality Assurance Resume Examples & Samples

Innovating solutions to work around system limitations
Understanding control procedures and disciplines
Working with version control and Jira or similar ticketing system
4-7 years of experience in software automation testing web applications, and or client/server applications
4-7 years of experience performing integration testing
Prior exposure providing testing deliverables within Agile and Scrum methodologies
Ability to generate test reports used for system acceptance
Previous experience conducting tests to verify software is ready for release into production

Specialist Quality Assurance Resume Examples & Samples

GMP review of batch documents
Responsible for metrics related equipment qualification
Communicate and resolve audit comments with client areas
Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards
Review and approval of SOPs
University degree in Quality, Engineering, Sciences or another relevant discipline
At least 1-3 years of experience within a GMP-regulated environment, preferably in the Pharmaceutical or Medical Devices industry
Broad working knowledge of cGMP regulations; basic understanding of manufacturing process
Ability to effectively work as part of a multidisciplinary, international team
Good verbal and written communication skills in English, additional German language are required

PFS Specialist Quality Assurance PBO Patient Accounting Resume Examples & Samples

Reviews current processes, assuring any changes are given to management, for the creation and updating of training manuals and other training material
Coordinates in the creation of process and training documents to be used to train new and current staff
Assists with vacancies by working the scheduled hours for a period of time
Provides assistance on projects in the department

Specialist Quality Assurance Resume Examples & Samples

Support data management for the QC systems
Perform analytical trend analysis and provide data verification for reports
Provide Quality oversight of QC laboratory unexpected results and out of trends
Support inspections and audits
Support QC network as a key stakeholder representing site QC
Support templating and qualification requirements for the Quality Control systems
Experienced in TrackWise NC, CAPA, Change Control
Strong communication skills (written and oral), facilitation and presentation skills
Strong organizational skills and ability to multi-task
Experienced in leading projects and teams

Specialist Quality Assurance Resume Examples & Samples

Product Disposition (Finished Drug Product & Inspected Drug Product)
Act as QA contact for all activities related to new product introductions and product life cycle management, including but not limited to change control review and approval
Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures
Act as QA contact for Non-conformances and CAPA’s
Lead and participate in ABR internal and external audits as needed
Write, review and approve procedures and/or job aids in compliance with corporate, site and regulatory requirements
Participate in global Quality initiatives ensuring that ABR input is provided and leading ABR implementation activities
Participate (lead) in various ABR projects and improvement efforts including (new) product launch teams
Masters in Science degree (e.g. in Pharmacy, Bio-engineering,…) and 3+ years of experience in pharmaceutical industry
Knowledgeable and skilled to fulfil the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 343/01 chapter 2.2 (Responsible Person)
Computer literacy