Amgen
Quality Assurance Manager
US - California - Thousand Oaks
Sponsorship not specifiedDetected 67 days ago
Supply ChainProcess ImprovementGMPFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingMentoring
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odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 92%
Of 75 labor certifications old enough to have been used, 6 expired without the employer filing the next step. Median time from filing to decision: 486 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
17 transfer filings in the last year, covering 17 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
- With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year.
- Our award-winning culture is collaborative, innovative, and science based.
Responsibilities
- Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensuring the facility operates successfully, efficiently, compliantly, and safely.
- Lead the quality assurance team with a focus on strategic direction, staff development, and maintaining a high-performance culture.
- Champion quality initiatives and collaborate with cross-functional teams to drive and deliver continuous improvement projects.
- Process optimization - assess and optimize quality processes to enhance efficiency and effectiveness Ensure compliance with cGMP practices and regulatory requirements.
- Provide leadership and support during both internal/external audits and inspections and audits.
- Develop and manage training programs to ensure team competencies and understanding of cGMP requirements.
- Manage quality-related issues effectively, ensuring solutions are implemented to prevent recurrence.
- Evaluate team performance and provide coaching to support career growth and professional development.
- A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
- This role could support a day or swing
Requirements
- Communication Skills: Exceptional communication and interpersonal skills, with the proficiency to interact effectively with all levels of the organization and external partners.
- Aseptic Knowledge: Expertise in aseptic processing and cleanroom operations, with a focus on maintaining sterility and preventing contamination.
- Audit and Inspection Readiness: Experience in preparing for and leading audits and inspections by regulatory authorities.
Nice to have
- Bachelor's Degree in Science 5 plus years of aseptic processing experience in
- QA or Manufacturing Regulatory Knowledge:
- Bachelor's Degree in Science 5 plus years of aseptic processing experience in QA or Manufacturing Regulatory Knowledge: Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements.
- Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements.
- Your managerial experience may run concurrently with the required technical experience referenced above.
Skills
- Excellent analytical and problem-solving skills, with the ability to make sound decisions based on data.
- A commitment to continuous improvement and staying current with the latest industry trends and best practices.
- Expertise in aseptic processing and cleanroom operations, with a focus on maintaining sterility and preventing contamination.
- Ability to identify, assess, and mitigate risks to product quality and patient safety.
- Experience in supporting manufacturing operations, with a focus on efficiency, compliance, and safety.
- Audit and Inspection Readiness:
- Experience in preparing for and leading audits and inspections by regulatory authorities.
- Analytical Thinking: Excellent analytical and problem-solving skills, with the ability to make sound decisions based on data.
- Communication
- Continuous Improvement: A commitment to continuous improvement and staying current with the latest industry trends and best practices.
- Risk Management: Ability to identify, assess, and mitigate risks to product quality and patient safety.
- Operational Excellence: Experience in supporting manufacturing operations, with a focus on efficiency, compliance, and safety.
Compensation
- 118,235.00USD -159,965.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Benefits
- shift schedule, including partial weekend coverage as part of the standard
- Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
Company info
- Career Category Quality Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- What we expect of you We are all different, yet we all use our unique contributions to serve patients.
Visa & Work Authorization
- Sponsorship Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.