QA Associate - Night Shift

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.

QA Associate - Night Shift

What you will do

Let’s do this! Let’s change the world!

In this vital role the Amgen North Carolina (ANC) Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, launch and commercial operations. The PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction in regard to deviations, quality systems and compliance.

The Plant Quality Assurance team shift structure aligns with Manufacturing, which is a 12-hr rotating shift work schedule.

• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.

• Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.

• Oversee and provide guidance during on-the-floor analytical testing.

• Support management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks.

• Perform training activities, as needed.

• Support operational improvement initiatives, programs and projects.

• Collaborate as part of a cross-functional team (i.e., Mfg, QC, F&E (Facilities & Engineering), PD (Process Development), Regulatory, etc.) in completing production activities

• Strong cGMP and GDP behaviors

• Demonstrated experience with deviations and CAPA records

• Previous experience supporting GMP testing laboratories.

• Knowledge of electronic systems including LIMS, Trackwise, and Maximo

• Strong presentation, database and spreadsheet application skills

• Strong organizational skills and ability to manage multiple tasks at one time

• Ability to follow assignments through to completion and meet timelines

• Exposure to regulatory agency inspectors or participation in regulatory agency audits.

• Strong technical communication skills, both written and oral

• Demonstrated ability to work as a team player and independently

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a team player with these qualifications.

Basic Qualifications:

• High school/GED + 2 years quality, manufacturing and/or other regulated environment] work or military experience OR

• Associate’s + 6 months quality, manufacturing and/or other regulated environment work or military experience

Preferred Qualifications:

• Experience in a regulated industry such as biotechnology or pharmaceutical, General understanding of aseptic techniques, cGMPs, gowning, sampling procedures and safety guidelines

• Basic understanding and process experience in a cGMP manufacturing facility

• Excellent verbal and written communication

• Work as a team player and/or independently

• Multi-task, ability to shift priorities and basic problem solving skills

• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

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

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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.