Career Category
Quality
Job Description
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.
Specialist Quality Assurance – Deviations Lifecycle
Live
What you will do
Let’s do this. Let’s change the world! In this vital role you will support the Amgen Manufacturing Limited - Drug Substance and Support areas, non-standard shift operations. As Specialist QA you will bring forth out of the box thinking, an agile attitude with a subject matter expertise and innate understanding of Quality processes and controls. Specific responsibilities include but are not limited to:
You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, including but not limited to Deviation’s and CAPAs.
Actively engage in Continues Improvement initiatives, programs and projects. Being also the continuous improvement champion.
Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
Certify that deviations from established procedures are optimally investigated and documented.
Teamwork and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
Strategic advisor to senior management of quality, compliance, supply and safety risks.
Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
Accountable for assigned training adherence to execute the appropriate tasks.
Support non-standard shift and extended hours including weekends, as per business needs in a remote work setting with the flexibility to be onsite if it is needed.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Specialist QA professional we seek is an Individual Contributor Leader with these qualifications.
Doctorate degree
OR
Master’s degree & 3 years of Quality and/or Manufacturing support GMP regulated environment experience
OR
Bachelor’s degree & 5 years of Quality and/or Manufacturing support GMP regulated environment experience
Beyond that, additional preferred qualifications are:
Educational background in Life Science and/or Engineering.
Validated expertise in Quality Systems such as Deviations, CAPA, and Change Control.
Experience in electronic systems such as: Maximo, ARMS, Trackwise, MES, LIMS, SAP, PI Historian and/or PCS.
Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
Robust knowledge 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), Performance Qualification (PQ), Protocols, Test Scripts, and/or Completion/Summary Reports approvals as per the compliance requirements.
Validated experience as Quality Contact for complex projects and in Commissioning and Qualifications.
Strong organizational skills, including ability to follow assignments through to completion.
Enhanced skills in leading, influencing and negotiating.
Ability to interact with regulatory agencies.
Proven word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills in English and Spanish.
Skills working independently and to effectively interact with all levels throughout the organization.
Advanced data trending & evaluation knowledge and ability to evaluate compliance issues.
Thrive
Some of the vast rewards of working here
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
A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. 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.
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