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For your reference, we have included the original job posting below.
Dir Quality Control
Job Number:
44074601
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Engineering & Architecture Manufacturing & Production
Dir Quality Control
Responsible for leading the operations of the Process & Chemical Analysis laboratories (Raw Materials, HPLC/CE, and Bioassay/Immunoassay/Gels) within Clinical QC. Assures that all laboratory areas comply with the established company policies, procedures, analytical methods and current Good Manufacturing Practices (cGMP). Manages resources and personnel to ensure product quality standards are met within the budgeted cost and in compliance with regulatory requirements. Key responsibilities include: • Accomplishes results through personnel supervision assuring on time and high quality results and reports. • Perform timely policy, process related and operational decisions that are within the limits of the company policies, procedures, as well as the regulatory agencies standards and regulations. • Oversee the implementation of quality plans and schedules. • Ensure the efficient use of resources. • May participate in establishing and aligning best practices across sites. • Lead efforts to ensure quality practices are consistent across the facilities and with other site quality operations. • Communicate and implement corporate initiatives and programs. • Recruit, develop, retrain and motivate outstanding staff. Assures compliance with cGMP training requirements for QC staff. • Support validation and production assignments according to schedule without compromising quality. Maintain high professional and compliance standards during production without sacrificing schedule. • Ensure that laboratory equipment and instrumentation is specified, procured, operates and maintained. • Develops and maintains appropriate protocols and procedures as needed. • Interact with regulatory agencies as needed. • Troubleshoots and provides support for manufacturing and process development groups. • Review QC documents, coordinates method development and qualification in analytical chemistry lab. • Coordination of Incident and formal investigations. • Perform management responsibilities associated to development, coaching, mentorship of QC staff, as well as the performance evaluation of direct reports.
Basic Qualifications Doctorate degree and 4 years of directly related experience
OR
Master's degree and 8 years of directly related years
OR
Bachelor's degree and 10 years of directly related experience
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications •MS or PhD in life sciences or engineering •12+ years experience in GMP laboratory setting •6+ years management experience, ideally managing 20+ staff •Previous Lean, Six Sigma, and/or Operational Excellence experience