Thousand Oaks, California, United States · On-site
$82k–$111k/yr
Career CategoryQualityJob 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 il…
Skills: GMP Operations, Quality Assurance, Aseptic Behaviors, Manual Visual Inspection, Electronic Batch Review
Juncos, Puerto Rico, United States · On-site
Career CategoryQualityJob 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 il…
Skills: Quality Control, Sampling and Inspection, GMP, SAP, LIMS
Thousand Oaks, California, United States · On-site
$129k–$175k/yr
Career CategoryScientificJob DescriptionJoin 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 …
Skills: Safety Pharmacology, Nonclinical Safety Assessment, GLP Compliance, Regulatory Submissions, Cross-functional Collaboration
Juncos, Puerto Rico, United States · On-site
Career CategoryEngineeringJob DescriptionJoin 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…
Skills: Process Development, Scale-up, Technology Transfer, Downstream Manufacturing, Statistical Data Analysis
Thousand Oaks, California, United States · On-site
$71k–$96k/yr
Career CategoryManufacturingJob 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 seri…
Skills: Cleanroom Operations, CIP/SIP, Aseptic Processing, Technical Writing, Delta V
Thousand Oaks, California, United States · Hybrid
$151k–$204k/yr
Career CategoryCorporate ServicesJob DescriptionJoin 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 …
Skills: Enterprise Program Management, Transformation Management, SAP S/4HANA, Change Management, Stakeholder Engagement
Cambridge, Massachusetts, United States · On-site
$126k–$171k/yr
Career CategoryScientificJob DescriptionJoin 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 …
Skills: Biologics Process Development, Formulation Development, Fill-finish Process Engineering, Statistical Design Of Experiments, Technical Transfer
New Albany, Ohio, United States · On-site
$105k–$142k/yr
Career CategorySupply ChainJob DescriptionJoin 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 seriou…
Skills: GMP/GDP Compliance, Quality Systems Management, CAPA, Change Control, Risk Assessment
Cambridge, England, United Kingdom · Hybrid
Career CategorySales & Marketing OperationsJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all …
Skills: Veeva CRM, Tableau, Sales Operations, Territory Management, Data Governance
Lisbon, Portugal · Hybrid
$27k–$36k/yr
Career CategorySales & Marketing OperationsJob Description Join our team at AMGEN Capability Center Portugal, consistently recognized among the top companies in the Best Workplaces™ ranking by Great Place to Work® in Por…
Skills: Business Analytics, Data Visualization, SQL, Microsoft Excel, Microsoft PowerPoint
Birmingham, Alabama, United States · Remote OK
$157k–$212k/yr
Career CategoryMedical AffairsJob Description 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. Si…
Skills: Scientific Communication, KOL Engagement, Oncology Expertise, Medical Affairs, Clinical Research
Thousand Oaks, California, United States · Remote OK
$249k–$337k/yr
Career CategoryScientificJob DescriptionJoin 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 …
Skills: Digital Pathology, Computational Pathology, AI/ML Model Development, Toxicologic Pathology, FAIR Data Curation
Thousand Oaks, California, United States · On-site
$79k–$107k/yr
Career CategoryQualityJob 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 il…
Skills: Microbiological Testing, Environmental Monitoring, GMP Documentation, Bioburden Testing, Microbial Identification
Thousand Oaks, California, United States · Remote OK
$160k–$217k/yr
Career CategoryResearchJob 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 i…
Skills: Health Economics, Outcomes Research, HEOR Strategy, Patient Reported Outcomes, Clinical Outcomes Assessment
Lexington-Fayette, Kentucky, United States · Remote OK
$158k–$222k/yr
Career CategoryCorporate ServicesJob Description Must live in Kentucky 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 serv…
Skills: Patient Access, Reimbursement Management, Prior Authorization, HIPAA Compliance, Coding And Billing
Thousand Oaks, California, United States · Remote OK
$275k–$372k/yr
Career CategoryClinical DevelopmentJob DescriptionJoin 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 wit…
Skills: Clinical Development, Cardiovascular Medicine, Clinical Trial Design, Regulatory Submissions, Medical Leadership
Jacksonville, Florida, United States · Remote OK
$157k–$212k/yr
Career CategoryMedical AffairsJob 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 se…
Skills: Scientific Exchange, Clinical Research, KOL Engagement, Medical Affairs, Respiratory Therapy
Los Angeles, California, United States · Remote OK
$129k–$175k/yr
Career CategoryClinicalJob Description Biostatistical Programming Manager What you will do Let’s do this. Let’s change the world. In this vital role you will provide both strategic oversight and hands-on statistical prog…
Skills: SAS Programming, R Programming, SDTM, ADaM, TFLs
Birmingham, Alabama, United States · Remote OK
$252k–$341k/yr
Career CategorySalesJob Description Region Covers: Florida, Texas, Alabama, Tennessee 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 …
Skills: Strategic Vision, Sales Management, Coaching, Performance Management, Succession Planning
Lisbon, Portugal · Hybrid
$68k–$92k/yr
Career CategoryCorporate ServicesJob Description Senior Manager, Corporate Affairs, Policy Communications, ELMAC HOW MIGHT YOU DEFY IMAGINATION? Join our team at AMGEN Capability Center Portugal, consistently recognized …
Skills: Policy Communications, Public Affairs, Stakeholder Engagement, Strategic Messaging, Healthcare Policy Analysis
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Provide daily quality oversight of Drug Product manufacturing areas to ensure processes and procedures align with regulatory requirements. Responsibilities include batch record review, manual visual inspection support, and the approval of minor deviations and GMP documentation.
Requires a combination of education and GMP experience, ranging from a high school diploma with 4 years of experience to a bachelor's degree with 6 months. Preferred candidates hold a science degree and demonstrate strong leadership and aseptic processing knowledge.
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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.
Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.
Duties include but are not limited to:
Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual
Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
Electronic batch review
GMP Document (SOPs/FORMs) revision review/approval,
Review and approval of electronic Maintenance documentation Work Order/Job Plans.
Quality support and approval of minor deviations,
Electronic Batch Record (MES) documentation revisions and approvals
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
Additionally:
Must be flexible with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility.
Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves)
Shift rotations will be required (Days, Swings, Graves) to support production schedule
We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is an employee with these qualifications.
High school/GED + 4 years of GMP experience OR
Associate’s + 2 years of GMP experience OR
Bachelor’s + 6 months of GMP experience OR
Master's
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
Experience managing projects through to completion meeting timelines.
Ability to evaluate documentation and operations according to company procedures.
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Display leadership attributes and drive improvement initiatives
Solid understanding and application of aseptic behaviors and principles
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A 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
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.
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.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
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.
.#WeareBiotech
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
#WeareBiotech
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
