Supervisor, QA (Night Shift)

Job Summary Oversee the Quality Support (Shop Floor QA) function at KBI Biopharma supporting the manufacture of biopharmaceuticals, providing QA support on the manufacturing floor. Lead the QA‑on‑the‑floor inspection program, review master and executed batch records, logbooks, room changeovers and room releases. Provide client project support to resolve issues related to GMP manufacturing as needed. Level load work across the team in support of batch release dates, daily manufacturing release schedules, and project priorities. Coaches and mentors staff. Responsibilities Supervise the Quality Support group supporting GMP manufacturing of bulk drug substance (Biologics). Manage QA oversight of ongoing GMP manufacturing activities. Perform QA‑on‑the‑floor inspections. Provide compliance support to manufacturing operators during processing on the floor. Perform QA batch record review of master and executed batch records. Provide client project support to resolve issues related to GMP manufacturing as needed. Work directly with Manufacturing Operations to resolve deviations and other compliance issues in a timely manner. Support deviations, CAPAs and change controls for Manufacturing Operations. Support document control for issuance of batch records as needed during off‑hours. Supervise direct reports providing coaching and mentoring. Attend relevant operational meetings in support of disposition activities. Support client audits and regulatory inspections as required. Minimum Requirements BS and 6+ year experience or MS and 4+ years’ experience in a quality engineering, quality on the floor, or technical services/manufacturing sciences role or equivalent. 0–2 years of supervisory experience preferred. Proficient in project management and quality systems. Strong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs, and FDA, EU, and ROW cGMP regulations. Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Physical Demands Support manufacturing and warehouse operations, including movement and/or lifting of raw materials and consumables. Computer Skills Word processing, database, spreadsheets, PowerPoint, internet, e‑mail, calendar management. Shift Information Night shift 2‑2‑3 schedule with a 15% shift premium. Benefits We offer a challenging, rewarding and fast‑paced environment with opportunities for career advancement through the development of technical skills. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. #J-18808-Ljbffr