Senior Quality Assurance Specialist

Job Category: Biotech/R&D/Science Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job SummaryDemonstrates the ability to function independently and productively. Displays strong investigative orientation with independence in the preparation of investigation and deviation reports. Responsible for providing quality assurance support to manufacturing and testing operations relative to the production of commercial and/or clinical products. 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 guidance. Will work with project teams providing services to the manufacturing operations for Drug substance and Drug Product to assure appropriate consistency in GMP systems applied across both clinical and licensed products. Incumbent has considerable knowledge in Quality Assurance as well as general knowledge across many areas of Operations, Validation, Engineering and Regulatory Affairs. Job Responsibilities*Identifies complex technical problems and provides guidance and support to quality systems development, implementation and maintenance efforts to ensure alignment with department business process needs and user requirements*Reviews batch records (MFRs, MBRs, QBRs) and gives disposition (approval, rejection, etc.) to the lot or material produced to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released.*Authors, reviews and edits documents, protocols, reports and Regulatory filings as required. Trains staff as necessary to ensure compliance with functional, GMP, and corporate training requirements. *Authors / reviews SOPs. Participate in local, research, and corporate compliance audits and correct deficiencies as required. Creation/review/approval of deviation investigations/reports, out-of-specification investigations, atypical result investigations, etc. Actively participates in investigations and compliance related issues. Organizes and provides written and /oral presentations of work.Basic Qualifications*BS w/12+ years.*MS w/10+ years.*PhD + 2 years.*Working knowledge with database and/or electronic document management systems required (Microsoft Word, Excel) and familiarity with other software a plus (Microsoft Project, Access, etc.). Knowledge of cGMP practices preferred.*With BS or MS degree, 10-12+ years experience in a regulated environment in Quality Assurance, Quality Control, Compliance or Manufacturing. PhD. and 2 years experience in a regulated environment in Quality Assurance, Quality Control, Compliance or Manufacturing.*Experience with validation processes (systems, utilities, methods, and process) and manufacturing processes within a regulated environment and experience with bio/pharmaceutical equipment, systems, and utilities are required.*Bio/pharmaceutical unit operations, aseptic processing, validation technology experience are a plus.*Excellent oral/written communication and presentation skills.Relocation is not available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None Zip Code :US-NY-Pearl River Leading the way to a healthier world.