Senior Specialist, Quality Assurance Job Description
Senior specialist, quality assurance
provides operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints.
Senior Specialist, Quality Assurance Duties & Responsibilities
To write an effective senior specialist, quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included senior specialist, quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Identifies, classifies and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints
Work with CMO/CROs to assess out of specification results, investigations, and deviations to closure in a compliant manner and ensure timely implementation of corrective actions (escalate as necessary)
Responsible for review of investigations and quality systems related to disposition of specific batches
Responsibility for Analytical support as part of the Calibrated Quality oversight, including Analytical Deviations related to validation testing, product release or stability testing
Reviewing drug product annual review report sections
Supporting departmental projects
Assist to plan annual audit schedule
Plan, prepare and perform audits according to the audit schedule
Plan, prepare and coordinate contract audits according to the audit schedule
Prepare and review audit reports in a timely manner
Senior Specialist, Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Specialist, Quality Assurance
List any licenses or certifications required by the position: ISO, 9001, CQA, ACRP, N45, ANSI, PMP, ITIL, ASQ, CAMS
Education for Senior Specialist, Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the senior specialist, quality assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Science, Chemistry, Biology, Technical, Microbiology, Education, Computer Science, Manufacturing, Life Science
Skills for Senior Specialist, Quality Assurance
Desired skills for senior specialist, quality assurance include:
Principles
Application of concepts
Technical capabilities to perform varied tasks
Quality systems and approaches
CAPA management
Change control
Deviations
Investigations
Product complaints
Relevant regulations and guidances in order to act as a resource for colleagues
Desired experience for senior specialist, quality assurance includes:
Ensure the establishment of an appropriate audit responses and timescale of corrective actions in cooperation with vendors and stakeholders
Monitor vendor corrective and preventive actions
Participate in Inspection Readiness activities including FDA "Mock" inspections, training and support activities
Support Regulatory and Third Party Inspection
Create/revise procedures and other documentation related to sphere of responsibility
Thorough experience auditing GMP regulated areas
Senior Specialist, Quality Assurance Examples
1
Senior Specialist, Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of senior specialist, quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior specialist, quality assurance
- Responsible for review of all criteria required for disposition of raw materials and products
- Responsible for collaborating with key stakeholders including but not limited to Supply Planning, Materials Management and Supplier Quality relative to raw material quality concerns and batch disposition planning
- Master Batch Record review and approval
- Executed Batch Record reviews and approvals
- Responsible for adherence with the quality agreement provisions
- Ensure GMP compliance profile is maintained
- Ensure product is stored and transported at appropriate temperature conditions and per validated or qualified shipper
- Manage sample retention program and periodic re-inspection activities and reporting as required
- Provide Quality input for process and method monitoring and annual product quality reports
- Support material review board meetings
Qualifications for senior specialist, quality assurance
- Ability to present audit findings in a clear, concise and diplomatic way to all levels of Management
- MasterControl experience or other audit database
- Experience with Risk Assessment, Controls and Management
- Requires a Bachelor's Degree in Microbiology, Biology, Chemistry (Or closely related degree with these core courses as the foundation)
- Requires eight (8) years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas
- Demonstrated hard-working and productive work ethic in an ambiguous environment strongly preferred
2
Senior Specialist, Quality Assurance Job Description
Job Description Example
Our company is looking to fill the role of senior specialist, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior specialist, quality assurance
- Schedule, lead, and/or participate in the quarterly Site Management Review and documents outcome
- Perform trending analysis related to quality systems and generate associated reports for quality and site management as required
- Draft, review, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications
- Investigate non-conformances as they pertain to the manufacturing and testing of pharmaceuticals and medical devices
- Drive continuous improvement of site quality systems
- Coordinate and perform the drafting of Quality Agreements with suppliers of materials/services and with customers
- Work with global quality team to gather complaints records, input into Track Wise system and support global quality team to perform investigation per corp
- Performance management of QA Specialists assigned to the projects over which he/she has QA management responsibility
- Manage and mentor QA Specialists in the execution of their tasks & responsibilities
- Represent QA at interdepartmental meetings
Qualifications for senior specialist, quality assurance
- Very good knowledge of English, French would be an asset
- At least 8-10 years of experience in QA, with focus on bioanalytical, (FDA) and agrochemical (EPA)
- Ability to estimate LOE for test development, test execution, and other test activities
- Quickly earns the respect and trust of other developers
- Computer Science or similar degree or appropriate experience that would make the candidate effective in this role
- Familiarity in an automation framework and automated testing tools
3
Senior Specialist, Quality Assurance Job Description
Job Description Example
Our company is looking to fill the role of senior specialist, quality assurance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior specialist, quality assurance
- Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
- Reporting on the state of control of the Controlled Environment and Clean Utilities for the Chelsea Manufacturing Site
- Reporting on Quality Metrics for production related events
- Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
- Support of implementation of CAPA and review of CAPA effectiveness as determined through Discrepancies
- Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
- Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
- Provide support during compliance inspections conducted by external sources
- Active member of a self-directed work team with operations personnel to critically evaluate and continuously improve manufacturing control systems
- Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
Qualifications for senior specialist, quality assurance
- Proficiency with Microsoft applications such as Word, Excel, and PowerPoint
- Ability to travel internationally and domestically (travel up to 15%)
- Ability to review and interpret QC data including, but not limited to HPLC, GC, atomic absorption spectroscopy, compendial wet chemistry assays
- Demonstrated problem-solving skills with the ability to prioritize, align and simplify
- Strong customer focus and solution orientation
- Refined analytical and consulting skills
4
Senior Specialist, Quality Assurance Job Description
Job Description Example
Our growing company is hiring for a senior specialist, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior specialist, quality assurance
- Ensures completion of a comprehensive Test Plan
- Review test documents
- Leads the creation of Test Calendar
- Plans and coordinates the layout of the test phases and test cycles
- Plans and estimates resource needs and efforts
- Organizes and secures test resources including IT testers, vendor resources, environment support resources
- Identification of environment and test data needs, costing, budget, timeline, resourcing (in collaboration with the Resource Manager), scheduling, distribution of work
- Test Communication point for Developers, Testers, Coordinators, Project Managers, outside Vendors, Lines of Business and Test Practice Manager
- Ensure requirements traceability to test cases and test results
- Gain approvals from stakeholders
Qualifications for senior specialist, quality assurance
- The position will be nights 2am - 10am M-F
- Bachelor’s degree or a combination of Associate’s Degree in Biology, Biochemistry, Chemistry or other relevant discipline with minimum of three years of cGMP experience
- Ability to tolerate working in cold storage (-20°C) for short durations several times a week
- Professional experience in the fields of CAPA, Complaints and Design Control
- Degree (or equivalent work experience) ideally in a science based discipline
- Practical experience in a regulated environment, IVD instruments (ISO 9001/13485 and 21 CFR Part 820)
5
Senior Specialist, Quality Assurance Job Description
Job Description Example
Our innovative and growing company is looking for a senior specialist, quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior specialist, quality assurance
- Closely interact with and support manufacturing and quality personnel in all aspects of EM/ UM observations, process improvements and investigations
- Participate in multiple areas of the software development life cycle including interpreting designs, analyzing solutions, upfront discovery and prevention of defect introduction
- Design test plans which illustrate the automation test approach
- Contribute to the development and implementation of QA best practices and process improvements
- Be a senior team member, leading/ shepherding QA team activities
- Provide leadership to Agile teams in a matrix environment
- Be hands-on providing leadership to peers (50%-50%)
- Develops solutions to routine assigned activities of moderate scope & complexity
- Follows applicable Company / Unit procedures and may make updates to procedures and policies
- Works within and across functions for assigned Quality systems
Qualifications for senior specialist, quality assurance
- Strong understanding and commitment to professional auditing standards, risk assessment, regulations and compliance guidelines (e.g., IIA, GAAP, GAAS, COSO)
- Identify and manage issues on a continuous basis
- Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods)
- Minimum of 5 years’ experience with B.S./M.S
- 2-3 years’ experience in a regulated environment preferred - cGMP
- Experience, or familiarity with, Web development language and/or tool