Quality Assurance Specialist II

Position Title : QA Specialist II Operations Location: Bedford, New Hampshire Department: Quality Assurance Responsible For (Staff): No The QA Specialist II will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality System review. This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs. In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial product s ESSENTIAL DUTIES AND RESPONSIBILITIE S: Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organizat ionReview and approve master batch records for the timely initiation of GxP manufacturing activit iesResponsible for quality oversight and administration of the deviation/investigation and CAPA progr amsReview and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP complia nceProvide direction for complex investigations and CA PAsEnsure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CA PAsReview, develop, and improve quality system procedures, specifications, and test meth odsReview and approve CAPAs to prevent recurrence of deviati onsReview and approve Change Control documentat ionResponsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review proc essEstablish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely mann er.Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to managem entServe as QA representative to cross functional project teams such as tech transfer, process validation, and process improvem entPerform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organizat ionCoordinate change control review meeti ngsMonitor status of change controls and faciliti ze the approval proc essPerform risk assessments to comply with internal procedures and external guideli nesProvide training on department specific procedures and syst emsInterface with clients to address any documentation and compliance conce rnsInitiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applica bleEnsures site readiness for regulatory inspecti ons QUALIFICATI ONS: Requ ired:Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial produ ctionExperience performing RCA, technical writing, and working with quality related investiga tionsKnowledge of laboratory and production equipment and IQ/ OQ/PQKnowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such a s ICHExperience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with I CH Q9 Pre ferred:ASQ certification preferred Exceptional organizational skills and attention to detailAbility to make risk based decisions and resolve issues with minimal g uidanceExcellent interpersonal skills and the ability to communicate well orally and in writingProficiency in MS Office including Word, Excel, Access an d VisioExcellent verbal and written communication skills r equiredAbility to work in a dynamic, fast paced work envi ronmentHonesty, integrity, respect and courtesy with all col leaguesCreative with the ability to work with minimal supervision and balanced with independent t hinkingResilient through operational and organizational changeLess than 10% travel.This position may require additional hours and/or weeken #J-18808-Ljbffr PCI Pharma Services