Senior Associate Quality Assurance / Aseptic Coach

Amgen • Thousand Oaks, CA

4d

About The Position

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.

Requirements

• High school/GED + 4 years of GMP experience OR Associate’s + 2 years of GMP experience OR Bachelor’s + 6 months of GMP experience

Nice To Haves

• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field.
• Experience with coaching, delivering feedback, and/or leadership.
• Familiarity with Drug Product aseptic processing requirements.
• 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

Responsibilities

• Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
• Responsible for performing real-time aseptic oversight and coaching of filling activities on the manufacturing floor.
• Support real-time troubleshooting and triage with quality and aseptic compliance.
• Support quality related decision making involving non-routine interventions and documentation.
• Electronic batch record 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
• Support predominantly second/third shift work
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.

Benefits

• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED