Specialist Quality Assurance - Drug Product
BioSpace19 hours ago
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OnsiteFull-timeMid
Summary
Amgen is seeking a Specialist Quality Assurance - Drug Product to join their team in Thousand Oaks, CA. The role involves supporting the Plant Quality Assurance program and providing oversight of operational activities in aseptic Drug Product manufacturing.
About the Role
In this vital role, you will support the Plant Quality Assurance program by providing daily oversight of operational activities associated with aseptic Drug Product manufacturing. You will ensure compliance with quality systems, manage quality records, support tech transfers, and represent the Quality function in cross-functional projects. Responsibilities include quality oversight of manufacturing operations, reviewing controlled documents, and participating in audits and inspections.
About You
Required:
- Doctorate degree or a Master's degree with 2 years of quality experience or a Bachelor's degree with 4 years of quality experience or an Associate's degree with 8 years of quality experience or a high school diploma/GED with 10 years of quality experience.
Preferred:
- Bachelor's Degree in Science.
- 5 plus years of aseptic processing experience in QA or Manufacturing.
- Excellent interpersonal, verbal and written communication skills.
- Strong analytical skills for evaluating and interpreting information.
- Experience with problem-solving tools for root cause analysis.
- Strong leadership capabilities and experience with GMP requirements.
- Ability to independently interact with various levels and drive tasks to completion.
- Project management principles and techniques.
Benefits
- Comprehensive employee benefits package including medical, dental, and vision coverage.
- Retirement and Savings Plan with generous company contributions.
- Discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
BioSpace
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Thousand Oaks, CA