Sr. QA Specialist

Company: Renaissance LLC
Location: Lakewood
Posted on: May 4, 2021

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.OverviewThe Sr. QA Specialist reviews the deviations, change controls and validation documents with minimal supervision. The incumbent is involved in review of deviations for manufacturing process deviations and out-of-specification results through the various phases of the process. The incumbent participates in meetings related to deviations, CAPAs, and change controls. To prepare periodic performance reports. The incumbent will prepare annual product review reportsResponsibilities--- Review and approve deviations/investigations on priority basis.--- Follow up with investigators to ensure on time delivery of the investigations.--- Work with cross functional teams and coach, when needed, for a quality investigation. --- Communicate with customer on various stages of investigation in timely manner.--- Participate and conduct meetings with minimal supervision.--- Create and maintain metrics for investigations at the site. Report metrics on periodic basis.--- Write deviation summary reports including references from FDA/PDA/Other standard guidance, and cGMP with minimal supervision.--- Determine criticality of the investigation as soon as investigation is initiated.--- Review batch record documentation for accuracy and completeness as per Regulatory guidelines, GMPs and company procedures.--- Maintain follow-up with the other internal departments and external clients to assure timely completion of records for final product release.--- Review validation protocols per FDA guidelines/company procedures with minimal supervision in a timely manner.--- Review validation reports per approved validation protocols with minimal supervision in a timely manner.--- Review Change Controls per company procedures in a timely manner with minimal supervision.--- Write and revise procedures associated with deviations and change controls with minimal supervision.--- Keep track of Key Performance Indicators associated with the review activities and report to supervision. --- Assist in the preparation of annual product review reports--- Perform procedures to complete finished product release and lot disposition.--- Perform training as required.--- Perform other tasks as requested by management.QualificationsBachelor's Degree in related field and a minimum of 3 years of relevant experience in the pharmaceutical industry and knowledge of GMP standards, Quality Systems, and Health Authority Regulations PI135443072

Keywords: Renaissance LLC, Lakewood , Sr. QA Specialist, Other , Lakewood, New Jersey