Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)

Role: Senior Associate Plant QA (Night Shift) responsible for providing QA guidance, reviewing GMP batch records, and supporting quality systems in a biopharma manufacturing setting. Objectives include ensuring compliance with GMP standards, overseeing production quality during commercial batch labeling and packing, and supporting QA projects and audits. Responsibilities encompass supervising GMP operations, reviewing and approving batch documentation, managing deviations, CAPAs, and change controls, and fostering a quality culture within production teams. Qualifications required include a high school diploma plus 4 years of GMP/Quality experience, or an associate’s degree with 2 years, or a bachelor's degree with 6 months; a scientific or engineering degree and experience with GMP/GCP operations are preferred. Skills include strong attention to detail, communication, and familiarity with digital tools like SAP and TrackWise. High-value specifics: biologics manufacturing, GMP compliance, batch record review, Quality systems, and internal/external audits. The role involves direct contact with production, quality, and engineering stakeholders, supporting safety and operational excellence. Work setup is shift-based, primarily night hours, with no specific travel requirements stated.