Senior Associate Quality Assurance​/Aseptic Coach

Senior Associate Quality Assurance

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.

• 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.

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.

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

• 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

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.

• 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.

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.