Amgen Drug Product Quality Assurance Specialist Job in California

Amgen Drug Product Quality Assurance Specialist Job in California

Amgen is inviting applications for the Drug Product Quality Assurance Specialist position at its facility in Thousand Oaks, California, USA. This opportunity is suitable for Quality Assurance (QA) professionals with experience in pharmaceutical manufacturing, aseptic processing, GMP compliance, deviation investigations, CAPA management, and pharmaceutical quality systems.

The Amgen Drug Product Quality Assurance Specialist role is part of the Plant Quality Assurance organization and provides quality oversight for aseptic drug product manufacturing and inspection operations. The successful candidate will collaborate with Manufacturing, Facilities & Engineering, Quality Control, Supply Chain, and other cross-functional teams to maintain regulatory compliance and support safe, reliable manufacturing operations.

This position may be particularly relevant to pharmaceutical QA professionals seeking to advance their careers in the biotechnology industry. Candidates should review the job details, educational requirements, preferred experience, salary, and application instructions before applying.

Amgen Job Details

Job Information	Details
Company	Amgen
Job Title	Drug Product Quality Assurance Specialist
Job ID	R-247539
Location	Thousand Oaks, California, USA
Work Location Type	On-site
Department	Quality
Date Posted	October 1, 2026
Annual Salary Range	$104,287.35–$141,094.65 USD
Application Deadline	No fixed deadline stated
Official Careers Website	https://careers.amgen.com/

About the Drug Product Quality Assurance Specialist Role

The Amgen Drug Product Quality Assurance Specialist will work under minimal supervision to provide quality oversight of operational activities associated with aseptic drug product manufacturing and inspection areas.

The position requires an understanding of current Good Manufacturing Practices (cGMP), quality systems, regulatory expectations, and Good Documentation Practices (GDP). The selected candidate will help ensure that quality records are completed on time, investigations are adequately documented, corrective actions are implemented, and manufacturing operations comply with approved procedures.

The role also involves reviewing quality-related issues, providing recommendations, monitoring the progress of quality records, and representing the Quality function in projects that support departmental and manufacturing goals.

Key Job Responsibilities

1. Quality Oversight of Aseptic Manufacturing

The Amgen Drug Product Quality Assurance Specialist will provide QA oversight for drug product manufacturing and inspection activities.

Key responsibilities include:

• Monitoring manufacturing operations to ensure compliance with approved procedures.
• Providing quality oversight of inspection areas and utility systems.
• Supporting non-routine activities, including process and product validation.
• Working with operational teams to maintain quality and safety standards.
• Providing guidance on GMP requirements and site procedures.
• Helping ensure that manufacturing activities meet applicable regulatory expectations.

2. Deviation Investigations and CAPA Management

The position requires experience with quality investigations and corrective and preventive action processes.

Responsibilities include:

• Supporting root cause analysis for deviations and other quality events.
• Participating in risk assessments and identifying appropriate corrective actions.
• Reviewing and monitoring Corrective and Preventive Actions (CAPAs).
• Supporting effectiveness verification activities.
• Ensuring quality records are adequately documented and completed.
• Working with cross-functional teams to resolve issues and prevent recurrence.

Experience with structured problem-solving tools and investigation methodologies can help candidates demonstrate their ability to identify causes and support sustainable improvements.

3. Change Control and Quality Management Systems

The Amgen Drug Product Quality Assurance Specialist will support quality management system activities, including:

• Deviation management.
• Change Control.
• CAPA management.
• Risk Management.
• Controlled document revision, review, and approval.
• Tracking quality records through completion.
• Ensuring compliance with site procedures and regulatory requirements.

Candidates should be comfortable reviewing quality documentation, evaluating compliance issues, and coordinating with stakeholders to close records within established timelines.

4. Documentation and Regulatory Compliance

The role requires strong knowledge of GMP and GDP requirements.

The successful candidate will review and approve controlled documents, including Standard Operating Procedures (SOPs), protocols, and reports. The individual will also help ensure that manufacturing and inspection activities comply with applicable regulations, Amgen standards, safety requirements, and internal quality procedures.

Maintaining accurate, complete, and traceable documentation is essential in pharmaceutical manufacturing because quality records provide evidence that processes have been performed and controlled appropriately.

5. Audits, Inspections, and Continuous Improvement

The Amgen Drug Product Quality Assurance Specialist will participate in internal and external audits and regulatory inspections. Responsibilities may include responding to inspection-related questions, supporting the preparation of records, and working with teams to address compliance concerns.

The position also involves contributing to continuous improvement initiatives and digital innovation projects. The selected candidate will represent the Quality function in cross-functional projects designed to improve manufacturing operations and achieve plant goals.

Educational Qualifications and Experience

Amgen lists the following basic qualification pathways for this position:

• Doctorate degree, or
• Master’s degree with at least 2 years of quality experience, or
• Bachelor’s degree with at least 4 years of quality experience, or
• Associate’s degree with at least 8 years of quality experience, or
• High school diploma or GED with at least 10 years of quality experience.

Applicants should confirm that their education and experience satisfy one of the pathways specified in the official posting.

Preferred Qualifications

Amgen identifies the following qualifications and experience as preferred:

• Bachelor’s degree in Science.
• More than 5 years of aseptic processing experience in QA or Manufacturing.
• Strong experience in deviation investigations, root cause analysis, and CAPA development.
• Experience with Change Control and Risk Management.
• Knowledge of contamination control strategies.
• Familiarity with environmental monitoring programs and utility monitoring systems in GMP manufacturing environments.
• Experience participating in or managing corporate audits and regulatory inspections.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional, matrix-based organization.
• Analytical thinking and sound quality-related decision-making.
• Project management experience and the ability to lead cross-functional teams.
• Experience managing change and supporting continuous improvement initiatives.

Professionals with hands-on sterile manufacturing QA experience and a strong understanding of contamination control may be particularly well aligned with the preferred profile.

Salary and Employee Benefits

The advertised annual base salary range for the Amgen Drug Product Quality Assurance Specialist position is $104,287.35 to $141,094.65 USD, excluding Puerto Rico.

Actual compensation may vary depending on relevant experience, qualifications, skills, and other factors. Amgen also describes a Total Rewards Plan for eligible employees, which may include:

• Retirement and Savings Plan with company contributions.
• Medical, dental, and vision insurance.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus opportunities.
• Stock-based long-term incentives.
• Paid time-off programs.
• Career development opportunities.

Benefits are subject to eligibility, company policies, and the applicable plan terms.

Work Location and Application Deadline

This is an on-site position in Thousand Oaks, California, USA. Candidates should consider the location and any relocation or commuting requirements before applying.

Amgen states that the position has no fixed application deadline. Applications may continue to be accepted until a sufficient number of candidates have been received or a candidate has been selected. Sponsorship for this role is not guaranteed.

How to Apply for the Amgen QA Job

Interested candidates can apply through Amgen’s official recruitment portal.

Application steps:

1. Open the official job application link below.
2. Confirm the position title: Drug Product Quality Assurance Specialist.
3. Verify job ID R-247539.
4. Review the current eligibility criteria and complete job description.
5. Update your resume to highlight aseptic processing, GMP compliance, deviation investigations, CAPA, Change Control, contamination control, and audit experience.
6. Submit your application through the official recruitment system.

Apply online: Amgen Drug Product Quality Assurance Specialist – Official Application

For recruitment safety, apply through Amgen’s official careers website and never pay a fee to secure a job interview or employment.

Frequently Asked Questions

1. What is the job title at Amgen?

The position is Drug Product Quality Assurance Specialist.

2. Where is the job located?

The position is based on-site in Thousand Oaks, California, USA.

3. What is the salary range?

The advertised annual base salary range is $104,287.35–$141,094.65 USD.

4. How much experience is preferred?

Amgen prefers more than five years of aseptic processing experience in QA or Manufacturing, along with relevant quality experience and the required educational qualifications.

5. What are the key technical skills required?

Important skills include GMP compliance, deviation investigation, root cause analysis, CAPA, Change Control, Risk Management, contamination control, environmental monitoring, and audit support.

6. Is there a fixed application deadline?

No fixed deadline is stated. The vacancy may close once sufficient applications have been received or a candidate has been selected.

Conclusion

The Amgen Drug Product Quality Assurance Specialist vacancy in Thousand Oaks, California, offers an opportunity for experienced pharmaceutical Quality Assurance professionals to contribute to aseptic drug product manufacturing, regulatory compliance, and continuous improvement.

Candidates with relevant aseptic processing experience, strong investigation skills, CAPA expertise, and knowledge of pharmaceutical quality systems should review the official vacancy and apply if they meet the requirements.

Always verify the latest job status and application instructions through Amgen’s official careers portal before submitting your resume.