Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)

BioSpace; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Performance bonus

Stock options

Job summary

Amgen seeks a Sr. Associate Plant QA on the Night Shift to provide QA guidance for AOH production and perform Batch Record Reviews for commercial batches. You will collaborate with production operators, leads, supervisors, and support functions to uphold GMP and quality systems.

The role requires strong QA expertise, experience with GMP manufacturing, and the ability to interact across multiple disciplines. The position emphasizes safety, documentation accuracy, and process improvement.

Qualifications

• High school/GED with 4 years QA or GMP manufacturing experience, or an Associate with 2 years, or a BA with 6 months.
• Master's degree is considered advantageous for advanced QA roles.
• Preference for GMP/GLP regulated industry experience and data-driven quality work.

Responsibilities

• Provide daily guidance to Production staff on SOP and work instruction compliance.
• Monitor GMP operations in device assembly and packaging areas.
• Act as first contact for quality queries during packaging and labeling.
• Lead and coach teams on quality matters and promote a site quality culture.
• Review and approve batch production records and GMP documents.
• Perform finished product checks during commercial production.
• Compile batch records for lots manufactured, packaged, and labeled.
• Own and approve controlled documents, SOPs, and forms.
• Review deviations, CAPAs, and change controls; participate in inspections.
• Support Lean and Operational Excellence initiatives; uphold EHSS goals.

Skills

QA

GMP Manufacturing

Batch record review

Data entry

Communication

SAP

Education

High School Diploma or GED

Associate degree

Bachelor's degree

Master's degree

Tools

SAP

TrackWise

CDOCS

Job description

Sr. Associate Plant QA Night Shift

What You Will Do

Lets do this. Lets 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

• 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.

Basic Qualifications

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

OR

Associates + 2 years of Quality and/or GMP Manufacturing experience

OR

Bachelors + 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, well 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

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.

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.