Senior Associate Quality Assurance / Aseptic Coach

Amgen SA; Thousand Oaks (CA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Employee benefits package

Retirement and savings plan

Stock-based incentives

Award-winning time-off plans

Job summary

Amgen seeks a Senior Associate Quality Assurance / Aseptic Coach to support the Drug Product manufacturing floor in a 24/7 aseptic filling facility. The role provides real-time QA oversight, ensures compliance with GMP, and reviews electronic batch records and SOPs.

Ideal candidates will have GMP experience at different education levels and demonstrate leadership, strong documentation skills, and the ability to work both independently and as part of a team across rotating day/night shifts.

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 (not specified)

Responsibilities

• Purposeful presence on the manufacturing floor with gowning
• Real-time aseptic oversight and coaching of filling activities
• Support real-time troubleshooting and triage with quality
• Review/approve SOPs, documents, and deviations
• Electronic batch record review and MES documentation revisions
• Support second/third shift rotations to meet production
• Ensure compliance with GMP and regulatory requirements

Skills

GMP experience

Quality systems

Documentation practices

Leadership attributes

Team player / independent

Education

Bachelor’s in Biochemistry/ Biology/ Chemistry

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases.

With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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

Application deadline

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

Sponsorship for this role is not guaranteed.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.