Quality Specialist II

The QA Specialist II supports all business operations from a Quality perspective, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. The individual is capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. The individual also ensures business, quality and compliance goals are met in full compliance with all government‑issued environmental, health, safety, quality, and regulatory policies and guidelines. Primary Responsibilities: Support on the floor activities through shop floor QA procedures. Provide Quality input and guidance for deviations and laboratory investigations, technical documentation, program/process optimization projects, and audit readiness initiatives. Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities. Compile batch and testing documentation and generate certificates for release of testing and manufacturing batches within assigned timelines to effectively deliver results to client. Ability to review data and effectively identify trends or key issues. Ensure facility follows current GMP standards (cGMP). Support the development of quality systems including a robust and on‑going quality improvement system compliant with GMP. Complete line clearance and changeover activities to support product campaigns. Print master batch records to support client programs and internal manufactured products and aseptic manipulation qualifications. Oversee Aseptic process qualifications (APS) and vial inspections for APS and Drug product. Review environmental monitoring (EM) data to support changeover of suites as well as in process EM. Review material specs to support client programs. Review and approve new procedures. Facilitate review of document change controls for SOP revisions. Education, Experience, and Qualifications: Bachelor’s degree in a commercial or scientific field required. Minimum of 2 years experience within Pharmaceutical/Biopharmaceutical industry. 1-2 years in a Quality role within Pharmaceutical/Biopharmaceutical industry is preferred. #J-18808-Ljbffr Germer International