Night-Shift Quality Assurance Manager

Amgen

West Greenwich (RI)

On-site

USD 120,000 - 180,000

Full time

4 days ago
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Benefits offered by this job

Retirement and Savings Plan
Bonus program (discretionary)
Stock-based incentives
Paid time off (time‑off plans)
Flexible work models

Job summary

Amgen is seeking a Manager QA – Nights to lead Quality Assurance professionals for GMP manufacturing, with responsibility for night shift operations (M-F, 6pm–2:30am) and ongoing process improvements.

You will oversee procedures, investigations, CAPA, product release, validation, and change control while mentoring staff and partnering with cross‑functional teams to ensure compliant, efficient production.

Qualifications

  • Directly managing people and/or leadership experience leading teams, projects, programs, or directing resources.
  • Experience in manufacturing, investigations, CAPA, product release, validation and/or change control.
  • Knowledge of biotech manufacturing regulations and multi-product environments.
  • Ability to communicate clearly and present to audiences at all levels.
  • Decisive risk‑based decision‑making on the floor to support manufacturing needs.

Responsibilities

  • Hire, train, develop, and manage Quality Assurance professionals to successfully deliver on GMP manufacturing support and to manage change.
  • Oversee Night shift Quality Assurance teams; schedule is M-F 6pm–2:30am.
  • Reviewing and approving operational procedures and product manufacturing procedures, change controls, and validation reports.
  • Leading investigations and plant/site audits; partnering with management to resolve issues and drive change.
  • Represent QA on incident triage teams and support cross-functional projects to improve performance and compliance.

Skills

Leadership
Quality Assurance
Manufacturing
Process Improvement
Investigations

Education

Bachelor’s degree in Life Sciences, Engineering or related field
Associate’s degree
Master’s degree in related field
Doctorate degree

Job description

Amgen is seeking a Manager QA – Nights to lead Quality Assurance professionals for GMP manufacturing, with responsibility for night shift operations (M-F, 6pm–2:30am) and ongoing process improvements.

You will oversee procedures, investigations, CAPA, product release, validation, and change control while mentoring staff and partnering with cross‑functional teams to ensure compliant, efficient production.

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