Quality Assurance Specialist

The QA Specialist is a position which is responsible for assisting Quality management with the day-to-day operations of the various Quality Assurance functions at a critical vendor’s manufacturing site. This includes being the liaison between the vendor and our team, providing onsite quality support to the vendor’s team, review of change controls, procedures and other documents related to our products, and the disposition of materials in accordance with cGMP’s and Standard Operating Procedures.

ResponsibilitiesManage the document creation or revision process within project timelines using electronic systems. Documents may include procedures, specifications, master batch records and formsResponsible for the issuance of Working Batch RecordsIndependently review production batch records for accuracy, integrity and completionIndependently disposition materials, including product and raw materialsPrepare and/or approve Certificate of Analysis and Certificate of Conformance.Review and approve deviations, non-conformances and other information as deemed necessary. Investigate trends, prepare reports and notify management of issues needing further review.Participate in and/or support Quality audits (internal and external) with the support of Quality teamMaintain open communication between our team and vendorMaintaining training records and ensuring appropriate training is scheduledOther duties as assigned

Minimum Job QualificationsEducationBachelor’s degree is required (scientific field is preferred)Experience3-5 years of relevant work experience in Quality Assurance, Quality Control, or pharmaceutical manufacturing is requiredPrior work experience with cGMP batch release process

Knowledge/Skills/AbilitiesMust have a thorough understanding of cGMP’s and demonstrated working under/with GMP regulations for the pharmaceutical industryMust have a thorough understanding of quality systems such as Enzyme, Trackwise, Veeva (or similar)Ability to organize and write technical reportsAbility to self-direct and be resilient and focused under pressureGood project management skillsStrong computer skills and knowledge of word processing software and spreadsheet software. Must have solid working knowledge of MS Office suite (Word, Excel, PowerPoint, Access and Outlook).Competent in leading meetings, investigations and projectsAct with professionalism and treat others with respect and consideration regardless of their status or position