Sr. Quality Assurance Engineer

1 month ago

Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr. Quality Assurance EngineerLive

What you will do

Lets do this. Lets change the world. In this vital role you will be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.Responsibilities:

  • Co-develop training materials for stability method transfers with CPO
  • Ensures activities are in line with budget and support evidence-based resource needs
  • Provides Quality oversight to CPO activities and results (A)
  • Quality approval of protocols and technical reports for method development (D)
  • Provides advice to inform Quality Plan (A)
  • Provides advice and expertise to inform development of technical training materials for method transfer (A)
  • Oversight of protocols and requirements to outsource testing to labs (A)
  • Approved method development, validation, and transfer reports
  • Robust change controls, CAPAs, and NCs
  • Successful CPO method stewardship deliverables
  • Method training materials
  • Reports to manager CPOQ Core in Thousand Oaks.
  • Key advisor to Core Technologies Lead
  • Advisor to Innovation and Development Leads
  • Advisor to site quality organizations
  • Advisor to Product Quality Leaders (PQLs)
  • Collaborate with and/or provide advice to Regulatory to inform submissions
  • Align with Attribute Sciences where similar networks or governances are established
  • Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliersWin

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.Basic Qualifications:

    Doctorate degreeOr

    Masters degree and 2 years of quality experienceOr

    Bachelors degree and 4 years of quality experienceOr

    Associates degree and 8 years of quality experienceOr

    High school diploma / GED and 10 years of quality experiencePreferred Qualifications:

  • 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelors Degree in a Science FieldExperience in developing physical methods for combination productsFamiliarity with force measurement equipment, dimensional analysis, calibration, and lab GLPLeadership skills and the ability to coordinate multiple projects simultaneouslyFamiliar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025Ability to discern user requirements for input to method developmentAble to successfully manage workload to timelinesThrive

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.

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.

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:

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.comApplication deadlineExternal/Internal postings:

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.

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.

  • Sr. Quality Assurance Engineer

    1 month ago

    Thousand Oaks, California, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Sr. Quality Assurance Engineer

    3 weeks ago

    Thousand Oaks, United States BioSpace, Inc. Full time

    Job Details HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...

  • Sr. Quality Assurance Engineer

    1 month ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...

  • Sr. Quality Assurance Lead

    3 weeks ago

    Thousand Oaks, United States Omeat.bio Full time

    About Us Who doesn't love meat? Summer BBQs and friends around the campfire enjoying a succulent, delicious burger, packed with protein. Yep, meat rocks. The only problem is meat comes with baggage-greenhouse gasses, environmental degradation, nutritional concerns, and the welfare of animals. But what if the meat we love could be a force for good, helping...

  • Sr. Quality Assurance Lead

    1 month ago

    Thousand Oaks, United States Omeat.bio Full time

    Job DescriptionJob DescriptionSalary: 110-150K/yearAbout UsWho doesn’t love meat? Summer BBQs and friends around the campfire enjoying a succulent, delicious burger, packed with protein. Yep, meat rocks. The only problem is meat comes with baggage—greenhouse gasses, environmental degradation, nutritional concerns, and the welfare of animals. But what if...

  • Senior Associate Quality Assurance

    1 month ago

    Thousand Oaks, United States Ronin Staffing, LLC Full time

    Job DescriptionJob DescriptionHERE’S THE JOB DESCRIPTION:Title: MCS Senior Associate Quality Assurance #12932 (2 openings)Pay Rate: $33.00-36.00/hrLocation: Thousand Oaks, CA 91320Length: 3 year contractShift: Various shifts available - Must be flexible to support day/swing/night shifts  Candidates must be flexible with the hours they can work. ...

  • Sr. Quality Assurance Engineer

    3 weeks ago

    Thousand Oaks, United States VetJobs Full time

    Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set,...

  • Sr. Quality Assurance Lead

    1 week ago

    Thousand Oaks, United States Omeat.bio Full time

    Job DescriptionJob DescriptionSalary: 110-150K/yearAbout UsWho doesn’t love meat? Summer BBQs and friends around the campfire enjoying a succulent, delicious burger, packed with protein. Yep, meat rocks. The only problem is meat comes with baggage—greenhouse gasses, environmental degradation, nutritional concerns, and the welfare of animals. But what if...

  • Sr. Quality Assurance Lead

    1 week ago

    Thousand Oaks, United States Omeat.bio Full time

    Job DescriptionJob DescriptionSalary: 110-150K/yearAbout UsWho doesn’t love meat? Summer BBQs and friends around the campfire enjoying a succulent, delicious burger, packed with protein. Yep, meat rocks. The only problem is meat comes with baggage—greenhouse gasses, environmental degradation, nutritional concerns, and the welfare of animals. But what if...

  • Sr Quality Engineer

    2 months ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Sr. Quality Assurance Engineer

    3 weeks ago

    Thousand Oaks, United States VetJobs Full time

    Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set,...

  • Sr Engineer

    1 month ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Sr Engineer

    2 months ago

    Thousand Oaks, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading...

  • Sr Engineer

    1 month ago

    Thousand Oaks, California, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Quality Assurance Senior Associate, Supplier Quality

    3 weeks ago

    Thousand Oaks, United States FUJIFILM Corporation Full time

    Overview The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture...

  • Quality Assurance Specialist

    4 days ago

    Thousand Oaks, United States Planet Pharma Full time

    8 month contractPR 45-49.33/hr commensurate with experienceThousand Oaks, CA or RemoteThis role supports the Quality Disposition and Distribution of the company's clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good Distribution Practices. This includes...

  • Quality Assurance Specialist

    4 days ago

    Thousand Oaks, United States Planet Pharma Full time

    8 month contractPR 45-49.33/hr commensurate with experienceThousand Oaks, CA or RemoteThis role supports the Quality Disposition and Distribution of the company's clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good Distribution Practices. This includes...

  • Sr Engineer

    2 months ago

    Thousand Oaks, California, United States Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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...

  • Quality Assurance Specialist

    5 days ago

    Thousand Oaks, United States Meet Full time

    Our growing client is searching for a talented Quality Assurance Specialist to join their team. In this pivotal role you will support the Quality Disposition and Distribution of the company's clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good...

  • Quality Assurance Specialist

    4 days ago

    Thousand Oaks, United States Meet Full time

    Our growing client is searching for a talented Quality Assurance Specialist to join their team. In this pivotal role you will support the Quality Disposition and Distribution of the company's clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good...