Labratory Investigation Coordinator- Sr. Manager

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 SummaryGMP Laboratory Investigation Coordinator for Analytical and Quality Sciences. This position will work directly with the responsible laboratories to oversee the timely completion of high-quality investigation documents and reports, including thoroughness, accuracy, root cause definition, and appropriateness of CAPA (Corrective Action/Preventative Action) with respect to both science and compliance considerations. Timely, thorough, and well documented investigations are a requirement of cGMPs. This senior manager position will provide critical guidance and expertise in the closure of investigations and will work closely with the CPD Quality Unit to help AQS maintain a state of inspection readiness. The primary location is Pearl River, but responsibilities include coordinating investigations arising from Rouses Point, Montreal, and Gosport as well.Job ResponsibilitiesCoordinate GMP investigations (Laboratory Investigation Reports [LIRs] and Process Discrepancy Reports [PDIRs]) within CPD analytical laboratories to ensure timely completion of high-quality investigation documents and reports, including thoroughness, accuracy, root cause definition, and appropriateness of CAPA with respect to both science and compliance considerations, with the authority to assign CAPA responsibilities and due dates. This includes investigations conducted in Pearl River, Montreal, Rouses Point, and Gosport.Support inspection readiness activities within AQS/CPD, and serve as the Subject Matter Expert to discuss the investigations described above with inspectors or auditors. Inspections may be by government agencies, internal auditing groups, or third-party auditors.Review work of other scientists, as assigned, to ensure accuracy, completeness and compliance with departmental SOPs, and train scientists on investigation procedures.Satisfactorily completes all cGMP, GLP and/or safety training as applicable to job requirements. Where applicable, performs job responsibilities in compliance with cGMP, GLP and all other regulatory agency requirements.Performs other duties as assigned.Basic QualificationsBS /MS in chemistry or related science (Internal only) or a PhD in chemistry or related science with 8-10 years experience. A qualified person with significant scientific achievements in chemistry and pharmaceutical sciences, with a focus on investigations and compliance, can be considered as candidates with less than 8 years experience. Training will be provided by the department through SOPS, skills training aids, computer based training (CBT) courses and classroom training.Experience in analytical chemistry (eg, HPLC, LC-MS, NMR, and compendial methods). Experience in the pharmaceutical industry and cGMPs is required. Proper training will be provided by a combination of SOP reading, skills training aids, CBTs and classroom sessions. BS /MS in chemistry or related science plus over 15 yrs experience. Ph.D. requires 8 years of experience for this position level.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       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. 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.