QA Specialist

The QA Validation Specialist III/IV in the Development Quality Unit is responsible for a diverse and challenging set of activities, all of which are related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international GMP regulations and guidances as they relate to manufacturing systems, equipment and utility validation. The primary activities for which this position will be required to take a lead role include QA oversight for equipment, utility systems, cleaning, steaming, and computerized system validation; maintenance, calibration, along with the management of various quality systems including change control, change management, deviations, investigations, and corrective action plans. Other related activities include representing the Development Quality Unit in creation/review/approval of SOPs, qualification and/or validation protocols and reports for equipment and utility systems, related process/product investigations, calibration out-of tolerance reports, HVAC out-of-tolerance reports, maintenance work requests, and change management/change control documentation; defining and communicating QA acceptance criteria for related validation protocols and attending associated project team meetings.Activities for which this position may be required to participate in or take a lead role include, but are not limited to support of facility start-up, changeovers, and certifications, participation in quality system enhancement or implementation efforts to ensure alignment with department business process needs and compliance requirements, while fostering consistency between organizations. The position will also require partnering with commercial operations by providing services to the Clinical manufacturing operations for Drug Substance and Drug Product manufacturing and Andover Commercial Quality Unit counterparts to assure appropriate consistency in GMP systems applied across both clinical and licensed products.Requirements:
Requires B.S. in a relevant science-based discipline with a minimum of 6 years or M.S. with a minimum of 4 years in QA/QC and/or validation engineering position of increasing breadth of responsibility in the pharmaceutical or biotechnology GMP regulated industries. Candidate must have experience writing/executing/reviewing qualification/validation protocols for biopharmaceutical or pharmaceutical process equipment, and utility systems. Further, biopharmaceutical unit operations and aseptic processing experience are a plus. Must be flexible, organized, detail-oriented, have effective communication and leadership skills, and able to handle multiple priorities in a fast-paced, but consensus-based environment.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at