QA Specialist II. Quality Assurance, MAPS

Summary

Review GMP technical documentation to ensure quality standards are met and compliant with applicable SOPs, US FDA 21CFR210, 211, 11 and applicable ICH guidance documents. Revise QA procedures to strengthen cGMP compliance. 

Key Job Responsibilities

• Review test results and supporting technical documentation. Work directly with operations SMEs to resolve findings noted during the review process.
• Performing release of raw materials and consumables.
• Review and approve analytical equipment qualification documents.
• Reviewing and approving Certificate of Analysis for raw materials, drug substance and drug products.
• Supporting effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications trend reports and other quality documentation such as deviation and OOS investigation.
• Support writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.
• Providing QA support during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies.
• Support QA management with the support needed for compliance training.
• Maintaining workspace cleanliness by adhering to the 5S method of organization.
• Abiding by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
• This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.

Job Knowledge Required

• Bachelor's degree or equivalent in scientific discipline required.
• Preferred 2 – 3 years industry related work experience.
• Proficient experience and knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to contract laboratory.
• Proficient experience and knowledge of Analytical laboratories such as USP, Pharm. Eur. (EudraLex) and other applicable standards.
• Proficient knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.
• Proficient experience and knowledge in the use of LIMS and electronic documentation systems (i.e.SmartSolve, TrackWise).
• Strong interpersonal skills. Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.
• Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.
• Works on problems of diverse scope; exercises good judgement in selecting methods and techniques for obtaining solutions while handling Quality Assurance tasks.
• Ability to perform routine work with little instructions, requires general instructions on new assignments.
• Ability to work effectively under pressure in a rapidly changing environment.
• Ability to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.
• Ability to seek critical information from key resources to assist in problem solving.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).

Compensation Data

The annualized salary range for this position is between $69,000 - $107,800.