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. 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.
**SPECIALIST QA – DRUG SUBSTANCE OPS (NIGHT SHIFT)**
**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.
Your scheduled workweek may include extended shifts, Saturday and/or Sunday and/or 8/10/12hrs, second or third shift regularly, based on business need.
**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.
+ Ensure that deviations from established procedures are identified, reported, and documented per procedures.
+ Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
+ Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
+ Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
+ Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
+ Ensure completion of required training and maintain assigned training adherence to support successful task execution.
+ Collaborate and partner cross‑functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
+ Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
+ Alert senior management of quality, compliance, supply, and safety risks.
+ Provide support and oversight for 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 QA professional we seek is an individual contributor with these qualifications.
**Basic Qualifications:**
Doctorate degree
or
Master’s degree and 2 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
or
Bachelor’s degree and 4 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
or
Associate’s degree and 8 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
or
High school diploma / GED and 10 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
**Preferred Qualifications:**
+ Educational background in Life Sciences and/or Engineering.
+ Expertise in Quality Systems, including Deviations (Non‑conformities), CAPA, and Change Control.
+ Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
+ Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting‑level technical proficiency.
+ Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
+ Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
+ Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
+ Strong organizational skills, with the ability to drive assignments through successful completion.
+ Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
+ Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.
**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.
In addition to the base salary, 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:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
+ 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 an annual site shutdown
+ Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Sponsorship**
Sponsorship for this role is not guaranteed.
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 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.
