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Senior Associate QA - Thousand Oaks CA

Senior Associate QA - Thousand Oaks CA

VetJobsNewbury Park, CA, US
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Senior Associate QA - Thousand Oaks CA

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, education requirements, and experience, please follow the next steps.

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, including inspection support, ASP and QA assessments.
  • Electronic batch record review.
  • SOP revision approval.
  • Maximo System - Work order, job plan approvals.
  • Quality support and approval of minor deviations.
  • MES revisions and approvals.
  • Provide support for 24 / 5 Manufacturing.

Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

The vital attribute professional we seek is a [type of person] with these qualifications :

  • High school / GED + 4 years of Quality experience OR Associate's + 2 years of Quality experience OR Bachelor's + 6 months of Quality 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.

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    Senior Thousand Oaks • Newbury Park, CA, US