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Senior Associate Quality Assurance

Amgen SA
  • US
    Thousand Oaks, California, United States
  • US
    Thousand Oaks, California, United States

Über

Senior Associate Quality Assurance The Senior 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.
What you will do
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
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
What we expect of you 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.
Basic 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
Preferred Qualifications
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
What you can expect of us 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
Equal Opportunity Employer 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.
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  • Thousand Oaks, California, United States

Sprachkenntnisse

  • English
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