Manager / Sr. Manager, Quality Control

The Manager / Sr. Manager, Quality Control fulfills a critical role in the active pharmaceutical ingredient (API) manufacturing operations, responsible for managing and coordinating stability testing, raw material qualification, testing and release, and validation projects.

Requirements

• Manage and oversee execution of QC testing including IPC, API, raw material, validation, release, EM and microbial testing
• Supervise QC Scientists. Provide training, day-to-day scheduling, mentoring, and coaching for QC personnel
• Establish and revise specifications and sampling plans for IPC, raw materials and final product
• Develop and optimize new and existing analytical methods for qualification and release testing
• Coordinate stability program and the testing to meet stability endpoints, as needed
• Manage IPC release activities, raw material and API release activities to meet deadlines tied to manufacturing schedules
• Write, review, and approve QC Standard Operating procedures (SOP’s) as needed
• Evaluate, recommend, and implement new analytical technologies and instrumentation for raw material, final product, In process, microbial, environmental, and water testing
• Investigate Out-Of-Specification (OOS) test results, write reports and implement corrective and preventive actions (CAPA) to prevent recurrences
• Manage external test laboratories for contract testing of raw materials and other related testing
• Review test data for completeness and accuracy
• Provide timely responses to internal and external inquiries
• Stay abreast of new developments in analytical technologies
• Contribute to improvements in laboratory operations to increase efficiency and GMP compliance

Benefits

• Comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal and sick days