Specialist QA (AML 6 DS)
About the Job
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Amgen is looking for a Specialist QA - aligned to a nonstandard work scheduled, for our manufacturing operation at Puerto Rico site, Amgen Manufacturing Limited. As Specialist QA, you will bring forth out of the box thinking, an agile mindset, proven subject matter expertise and innate understanding of Quality processes and controls in support to a large-scale 24/7 drug substance manufacturing plant -AML6.
What you will do
Let’s do this. Let’s change the world! In this vital role you will oversight on-the-floor operations, you will be responsible to ensure that pharmaceutical products are manufactured, tested, stored and distributed according to cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products. Specific responsibilities include but are not limited to:
- Execute Quality disposition (approval or rejection) of bulk drug substances
- Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
- Ensures that deviations from established procedures are identified, reported and document per procedures.
- Ensures that changes that could potentially impact drug substance quality are assessed according to procedures
- Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
- Ensures that facilities, equipment, materials, organization, processes and procedures align with cGMP practices and other applicable regulations.
- Champion continues improvement initiatives, programs and projects. Developing efficiency projects and supervises progress.
- Accountable for assigned training adherence to permit the successfully completion of tasks.
- 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.
- Alerts senior management of quality, compliance, supply and safety risks
- Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
- Completes required assigned training to permit execution of required tasks
- Provides support and oversight of New Product Introduction (NPI)
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.
Master’s degree and 3 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
Bachelor’s degree & 5 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
Beyond that, additional preferred qualifications are:
- Educational background in Life Science and/or Engineering.
- Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control.
- Experience in electronic systems such as: Documentations platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
- Experience in computer systems validation or computer systems quality assurance (consulting background technical proficiency).
- Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, 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 drug substance/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.
- Microsoft Office spreadsheet and application skills and presentation 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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- 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
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.
Join us: careers.amgen.com
Equal 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.