Career Category
Quality
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Quality Assurance Specialist - PQA
Live
What you will do
Let’s do this. Let’s change the world. In this vital role, you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen’s Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems. Responsibilities include the following:
- Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
- Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
- Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
- Oversee and provide guidance during on-the-floor analytical testing.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Alert senior management of quality, compliance, supply and safety risks.
- Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
- Identification and implementation of continuous improvement opportunities within our processes and systems.
- Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a well-rounded team player with these qualifications.
Basic Qualifications:
- High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
- Doctorate degree
Preferred Qualifications:
- Educational background in Life Science or Engineering.
- Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
- Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
- Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian).
- Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
- Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
- Strong organizational skills, including ability to follow assignments through to completion.
- Excellent written and verbal communication skills.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
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.
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Salary Range
106,463.00 USD - 125,223.00 USD
