QA Specialist I

Responsible for providing Quality Assurance support to Manufacturing and laboratory testing operations relative to the production of commercial and/or clinical products. Reviews batch records and associated testing for cGMP compliance assuring that all specifications are met. Gives disposition (approval, rejection, etc.) to the material produced in the required electronic systems. Independently evaluates discrepancies found during review and determines appropriate action. Initiates investigations when required. Participates in planning record review priorities in order to meet release requirements. Incumbent knows and applies fundamental technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant Wyeth PPGs. Other duties include writing procedures, training, generating department metrics, and special projects as needed. The candidate must work with Operations, QA/QC, Technology, and other external groups under limited supervision. Candidate will work with enterprise systems used such as LIMS, SAP, TrackWise and MES.Bachelors of Arts/Science in a scientific or relevant discipline with 2 years related experience or Masters in a related field. Knowledge in current Good Manufacturing Practices, FDA regulations and site procedures. Strong organizational, communication, technical writing skills and attention to detail are required. Computer skills must include proficiency in word processing using MS Office. Knowledge in LIMS, SAP, TrackWise, MES and other enterprise systems is preferred.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