Senior Associate Quality Assurance / Aseptic Coach

What you will do

Let’s do this! Let’s change the world! 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 24/7 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 (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.

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

    • 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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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Salary Range