Sr. Associate Plant QA

Amgen; New Albany (OH); On-site; USD 82,000 - 111,000; Full time

Job summary

Amgen’s Quality team in Ohio seeks a Senior Associate Plant QA for day shifts to guide production staff, verify GMP operations, and review batch records. You will interact with operators, supervisors, and maintenance to ensure compliance with SOPs and quality systems.

The role requires GMP manufacturing experience and strong documentation skills, with opportunities to contribute to Lean initiatives and site-wide quality culture. Sponsorship not guaranteed; competitive benefits apply.

Qualifications

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

Responsibilities

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
• Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place
• Perform finished product checks during (commercial) production runs
• Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
• Review and approve Deviation, CAPA, and Change Control records.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

Skills

GMP experience

Verbal and written communication

Strong organizational skills

Attention to detail

Autonomy in tasks

Digital innovation affinity

ERP familiarity

Education

High school/GED + 4 years of Quality and/or GMP Manufacturing experience

Associate’s + 2 years of Quality and/or GMP Manufacturing experience

Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience

Master's

Tools

SAP

TrackWise

CDOCS

Job description

Career Category

Quality

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Sr. Associate Plant QA Day Shift

What you will do

Let’s do this. Let’s change the world. In this role As Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at AOH. Next to that, you will provide support in different QA related projects/systems.

In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering.

Responsibilities

Let’s do this. Let’s change the world. In this vital role you will:

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.

• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.

• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.

• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.

• Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take place

• Perform finished product checks during (commercial) production runs

• Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.

• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.

• Review and approve Deviation, CAPA, and Change Control records.

• Participate in self-led inspections and provide support during internal / external regulatory inspections.

• Support Lean Transformation and Operational Excellence initiatives

• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting EHSS corporate and site goals.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with any of these qualifications.

We also use Basic Qualifications:

High school/GED + 4 years of Quality and/or GMP Manufacturing experience

OR

Associate’s + 2 years of Quality and/or GMP Manufacturing experience

OR

Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience

OR

Master's

Preferred Qualifications:

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies

• Experience in and knowledge of GMP/GCP operations or similarly regulated industry

• Affinity with digital innovation, data sciences and Quality engineering

• Experience with raw material receipt, inspection & sampling

• Highly effective verbal and written communication skills, strong interpersonal skills

• Great attention to detail and high degree of accuracy in task execution and GMP documentation

• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

• Strong organizational skills, including ability to follow assignments through to completion

• Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.

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

Sponsorship

Sponsorship for this role is not guaranteed.

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.

Salary Range

82,081.95USD -111,052.05USD