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Senior Associate Quality AssuranceBioSpace, Inc. • Thousand Oaks, California, United States
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Senior Associate Quality Assurance

BioSpace, Inc.
  • US
    Thousand Oaks, California, United States
  • US
    Thousand Oaks, California, United States
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À propos

Senior Associate Quality Assurance This role supports Amgen’s Quality Assurance program under the Plant QA organization, providing daily oversight of drug product manufacturing areas. Responsibilities include ensuring regulatory compliance, reviewing documentation, and supporting quality systems.
What You Will Do
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
Additional Requirements
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 8 hrs to 12 hrs 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
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
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
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 and to perform essential job functions.
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  • Thousand Oaks, California, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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