Specialist Quality Assurance - Drug Product
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Two Specialist Quality Assurance-Drug Product positions are available for non-standard shift including second, third and weekend shift as normal schedule.Live
What you will do
Lets do this. Lets change the world! In this vital role you will bring forth out of the box thinking, an agile attitude and subject matter expertise and innate understanding of Quality processes in Amgen Manufacturing Limited, Drug Product operations, including formulation, filling, inspection, assembly, packaging, and solid dosage organizations. You will be responsible for the quality and compliance of major deviations. Specific responsibilities include but are not limited to:
- Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
- Responsible for Minor and Major Deviations, CAPAs, CAPA EVs as owners or Quality contact and all associated documents which include GMP document revision, and Quality System records with role of Quality contact. Ensuring that deviations from established procedures are investigated and detailed per procedures.
- Ensures true Root Cause are identified and appropriate corrective actions are implemented.
- Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.
- Support continues improvement initiatives, programs and projects. Developing efficiency projects and supervises progress.
- Ensures the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations.
- Accountable for assigned training adherence to permit the successfully completion of tasks.
- Strategic advisor and alerts senior management of quality, compliance, supply and safety risks.
- Teamwork and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
- Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Specialist Quality Assurance professional we seek is an individual contributor leader with these qualifications.
Masters degree and 3 years of Quality or Manufacturing support experience in pharmaceutical, medical device or biotechnology industry
Bachelors degree & 5 years of Quality or Manufacturing support experience in pharmaceutical, medical device or biotechnology industry
Beyond that, additional preferred qualifications are:
- Educational background in Life Science and/or Engineering.
- Expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control.
- Experience in electronic systems such as: Maximo, ARMS, Trackwise, LIMS and SAP.
- Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
- Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
- Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
- Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products with experience in commissioning and qualifications.
- Strong organizational skills, including ability to follow assignments through to completion.
- Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
- Word processing, presentation, database and spreadsheet application skills and knowledge.
- Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
- Validated skill in working independently and to optimally interact with all levels throughout the organization.
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.
Join us: careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.