Manager Quality Control
| Company | Amgen |
|---|---|
| Location | Thousand Oaks, CA, USA |
| Salary | $117706 – $139820 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD, Associate’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Doctorate degree
- Master’s degree and 3 years of Bioassay experience
- Bachelor’s degree and 5 years of Bioassay experience
- Associate’s degree and 10 years of Bioassay experience
- High school diploma / GED and 12 years of Bioassay experience
- Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Responsibilities
- Oversees the execution of testing including routine analysis, cell bank Stability and testing in support of technology transfer for analytical methodologies
- Provides Bioassay technical expertise/guidance to lab staff and within cross-functional Amgen teams
- Manages the Bioassay Lab daily operations in relation to planning and management of materials, critical reagents, equipment and laboratory staff
- Owns and reviews controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioassay Lab activities
- Ensures that the Bioassay Lab operations comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls
- Represents the Bioassay Lab during Amgen internal/external audits and inspections. Direct interaction with regulatory agencies during on-site inspections
- Provides oversight of Bioassay Lab Quality Systems records including Deviations, CAPAs and Change Controls
- Selects, develops and evaluates laboratory staff to ensure functional objectives are met.
Preferred Qualifications
- Advanced Degree in Scientific Discipline
- Strong knowledge in Bioassay Laboratory techniques
- Familiarity with the technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines.
- Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis.
- Proven leadership capabilities and experience applying GMP requirements in a Quality Control setting
- Demonstrated ability to develop, coach and mentor employees
- Excellent interpersonal, verbal and written communication skills with all levels within the organization
- Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment