Senior Associate QA

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 QA I

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.

This position works a rotating day shift, with five days worked for one week (ex: M, Tu, F, Sa, Su) and two days the following week (W, Th). Shift hours are 7am to 7pm.

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

• Provide Quality oversight during on-the-floor analytical testing.

• Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.

• Ensure that changes that could potentially impact product quality are assessed according to procedures.

• Ensure that deviations from established procedures are investigated and documented per procedures.

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

• Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.

• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.

• Alert senior management of potential quality, compliance, supply, or safety risks.

• Complete assigned training to permit execution of required tasks.

• Drive operational improvement initiatives, programs, and projects.

• Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals.

What we expect of you

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

Basic Qualifications:

• High school/GED + 4 years Quality Assurance work experience OR

• Associate’s + 2 years Quality Assurance work experience OR

• Bachelor’s + 6 months Quality Assurance work experience

• Master's

Preferred Qualifications:

• Experience working in a cGMP environment

• Experience with decision making

• Experience with analytical testing and/or general compendia testing

• Experience working with batch records and other GMP documentation

• Knowledge of data integrity requirements

• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)

• Experience collaborating within and across functional areas and demonstrated customer service focus

• Excellent written and verbal communication skills

• Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment

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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External/Internal postings:

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.

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.