Sr Associate QA - Nights
Amgen
August 18, 2026
Remote friendly (West Greenwich, RI)
United States
Operations
Sr Associate QA
What You Will Do
- Responsible for Plant Quality Assurance (PQA) on the floor in support of Manufacturing activities.
- Provide quality oversight to facilitate real-time decision-making regarding quality requirements and foster collaboration between Manufacturing and Quality.
- Provide coaching, guidance, and direction to Manufacturing, Quality Control, and Facilities/Engineering on compliance and quality systems.
Responsibilities Include:
- Provide quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP, and applicable regulations.
- Provide quality oversight during on-the-floor analytical testing.
- Ensure facilities, equipment, materials, processes, and procedures follow cGMP and applicable regulations.
- Investigate and document deviations per procedures.
- Ensure production records and testing results are complete, accurate, and documented per procedures and cGMP.
- Review and approve cGMP processes, procedures, and records (SOPs, batch records, deviations, logbooks).
- Author/review/approve quality documents (risk assessments, training materials, engineering/automation documents, protocols, reports).
- Alert senior management of potential quality, compliance, supply, or safety risks.
- Complete assigned training to execute required tasks.
- Drive operational improvement initiatives.
Qualifications
Basic Qualifications:
- High school/GED + 4 years Quality Assurance or manufacturing experience; OR Associate’s + 2 years; OR Bachelor’s + 6 months; OR Master’s.
Preferred Qualifications:
- Experience in a cGMP environment; decision making; analytical testing/general compendia testing; batch records/GMP documentation; data integrity requirements.
- Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams).
Total Rewards Plan (eligibility-based):
- Health and welfare plans; retirement/savings plan; discretionary bonus (or sales incentive for field sales); stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient number or candidate selection. Sponsorship not guaranteed.
What You Will Do
- Responsible for Plant Quality Assurance (PQA) on the floor in support of Manufacturing activities.
- Provide quality oversight to facilitate real-time decision-making regarding quality requirements and foster collaboration between Manufacturing and Quality.
- Provide coaching, guidance, and direction to Manufacturing, Quality Control, and Facilities/Engineering on compliance and quality systems.
Responsibilities Include:
- Provide quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP, and applicable regulations.
- Provide quality oversight during on-the-floor analytical testing.
- Ensure facilities, equipment, materials, processes, and procedures follow cGMP and applicable regulations.
- Investigate and document deviations per procedures.
- Ensure production records and testing results are complete, accurate, and documented per procedures and cGMP.
- Review and approve cGMP processes, procedures, and records (SOPs, batch records, deviations, logbooks).
- Author/review/approve quality documents (risk assessments, training materials, engineering/automation documents, protocols, reports).
- Alert senior management of potential quality, compliance, supply, or safety risks.
- Complete assigned training to execute required tasks.
- Drive operational improvement initiatives.
Qualifications
Basic Qualifications:
- High school/GED + 4 years Quality Assurance or manufacturing experience; OR Associate’s + 2 years; OR Bachelor’s + 6 months; OR Master’s.
Preferred Qualifications:
- Experience in a cGMP environment; decision making; analytical testing/general compendia testing; batch records/GMP documentation; data integrity requirements.
- Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams).
Total Rewards Plan (eligibility-based):
- Health and welfare plans; retirement/savings plan; discretionary bonus (or sales incentive for field sales); stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient number or candidate selection. Sponsorship not guaranteed.