Quality Assurance Senior Associate
Listed on 2026-08-27
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager, Production QC/QA
Quality Assurance Senior Associate
Duration: 12 Months
Location:
West Greenwich, RI
Schedule:
Rotating 12-hour shifts, 6:45 AM – 7:00 PM Week 1:
Monday, Tuesday, Friday, Saturday Week 2:
Sunday, Wednesday, Thursday
The Plant Quality Assurance (PQA) Associate will provide on-the-floor Quality oversight in support of Manufacturing activities, including bulk drug substance operations. This role will work closely with Manufacturing teams to ensure compliance with cGMP requirements and support real-time decision-making related to quality requirements and deviations.
Key Responsibilities- Provide Quality oversight to ensure products are manufactured, tested, stored, and distributed in compliance with applicable regulations.
- Ensure facilities, equipment, materials, processes, procedures, and products follow cGMP and other regulatory requirements.
- Review and approve cGMP processes, procedures, documents, and records.
- Review batch records, logbooks, work orders, attachments, and other GMP documentation.
- Ensure deviations from established procedures are properly documented.
- Verify production records and testing results are complete, accurate, and compliant with written procedures and cGMP requirements.
- Identify and escalate quality, compliance, supply, and safety risks to management.
- Collaborate with Manufacturing and the PQA shift team to ensure required activities are completed.
- Complete all required training and maintain qualification for assigned tasks.
- Spend the majority of the shift in a cleanroom environment, including gowning in and out of frocks and coveralls.
Skills & Qualifications
- GMP/cGMP experience is mandatory.
- Experience in Quality Assurance and/or Manufacturing within a regulated environment.
- Knowledge of batch records, logbooks, deviations, and GMP documentation.
- Understanding data integrity requirements.
- Strong decision-making and problem-solving skills.
- Ability to work independently while effectively collaborating within a team.
- Proficient in MS Office:
Outlook, Word, Excel, PowerPoint, and Teams. - Excellent written and verbal communication skills.
- Ability to prioritize tasks and work effectively in a fast-paced environment with minimal oversight.
- Comfortable working in a cleanroom environment for the majority of the shift.
- Preferred Qualifications
- Bachelor's degree with 2+ years of Quality or Manufacturing experience.
- Experience working in a cGMP environment.
- Experience with analytical testing and/or general compendial testing.
- Experience reviewing and working with batch records and other GMP documentation.
- Demonstrated ability to collaborate across functional teams with a strong customer-service focus.
The annual salary for this position is between $27.00 - 28.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance], [paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].
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