Drug Product Quality Assurance Specialist

Amgen; Thousand Oaks (CA); Sur place; USD 104 000 - 141 000; Plein temps

Avantages offerts par ce poste

Stock-based incentives

Retirement plan

Medical, dental and vision coverage

Discretionary annual bonus

Résumé du poste

Amgen’s Thousand Oaks site seeks a Drug Product Quality Assurance Specialist to provide quality oversight for aseptic manufacturing and inspection areas. You will ensure compliance with cGMP, quality systems, and regulatory expectations while partnering with Manufacturing, Facilities & Engineering, QC, and cross-functional teams.

The role emphasizes CAPA, deviations, change controls, and document control with exposure to audits and regulatory inspections.

Qualifications

• Doctorate degree OR Master’s degree with 2 years of QA experience.
• Bachelor’s degree with 4 years QA experience.
• Associate’s degree with 8 years QA experience.
• High school diploma / GED with 10 years QA experience.

Responsabilités

• Provide Quality oversight to aseptic drug product manufacturing and inspection areas.
• Collaborate with Manufacturing, Facilities & Engineering, and QC to ensure regulatory compliance.
• Review and approve controlled documents and change controls.
• Participate in internal and external audits and inspections.
• Drive CAPA programs, root cause analysis, and risk assessments.

Connaissances

Quality Assurance

GMP

CAPA

Change Control

Root cause analysis

Documentation

Audits

Cross-functional collaboration

Formation

Doctorate/PhD or Master’s + 2 years of QA experience

Bachelor’s degree + 4 years QA experience

Associate’s degree + 8 years QA experience

High school/GED + 10 years QA experience

Description du poste

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. Our shared mission—to serve patients living with serious illnesses—drives all that we do. 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Drug Product Quality Assurance Specialist

In this vital role within the Plant Quality Assurance organization the Drug Product QA Specialist provides Quality oversight to operational activities associated with the aseptic Drug Product manufacturing and Inspection areas at Amgen, Thousand Oaks. Under minimal supervision, the role ensures adherence to cGMP requirements, quality systems, and regulatory expectations while partnering closely with Manufacturing, Facilities & Engineering, and other cross‑functional teams to support safe, compliant, and reliable operations.

What you will do

Let’s do this. Let’s change the world.

• Ensuring timely delivery and completion of records within our Quality Management System, including Deviations, Corrective Actions and Preventive Actions (CAPAs), Change Controls and document revision, review and approval.
• Partnering closely with Manufacturing, Facilities & Engineering, Quality Control, and other cross‑functional stakeholders to ensure events are thoroughly investigated, appropriately documented, and resolved in accordance with regulatory requirements and site procedures.
• Evaluating compliance and operational issues, providing recommendations and oversight, and ensuring progress of quality records to completion.
• Representing the B20 Quality function in projects as necessary to achieve departmental and plant goals and working in a dynamic cross functional environment.

Responsibilities

• Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross‑functional stakeholders to facilitate root cause analyses, risk assessments, CAPAs, and effectiveness verification activities.
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
• Partners with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
• Provides Quality Oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as nonroutine activities such as process and product validation.
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
• Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Participates in Amgen internal/external audits and inspections.
• Directly interacts with regulatory agencies during on‑site inspections.
• Contributes to and drives continuous improvement projects in cross‑functional collaboration.
• Represents the Quality function and provides quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
• Contributes to and drives digital innovation solutions and applications in cross‑functional collaboration.

Basic Qualifications

• Doctorate degree OR Master’s degree and 2 years of quality experience
• Bachelor’s degree and 4 years of quality experience
• Associate’s degree and 8 years of quality experience
• High school diploma / GED and 10 years of quality experience

Preferred Qualifications

• Bachelor’s Degree in Science 5 plus years of aseptic processing experience in QA or Manufacturing
• Strong experience supporting deviation investigations, root cause analysis, CAPA development, and Quality Management System processes such as Change Control and Risk Management
• Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners at all levels within the Organization
• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality‑minded conclusions
• Experience applying problem solving tools for root cause analysis.
• Experience participating in, managing, and responding to corporate audits/regulatory inspections
• Demonstrated ability with project management, initiating and leading cross‑functional teams, leading and managing change

What you can expect from us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity Employer

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Salary Range

104,287.35USD -141,094.65 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. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 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. 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen