Quality Assurance Associate

About the role

We are seeking a Plant Quality Assurance Specialist to provide on-the-floor quality oversight within a regulated biopharmaceutical manufacturing environment. This individual will partner closely with Facilities & Engineering, Process Development, Incoming Quality, Warehouse, and Manufacturing teams to ensure operations comply with cGMP requirements, internal procedures, and applicable regulatory standards.

Responsibilities

• Provide quality oversight for Facilities & Engineering, Incoming Quality, Warehouse, Raw Material Sampling, Process Development, and Manufacturing activities.
• Ensure facilities, equipment, materials, processes, and products meet cGMP and regulatory requirements.
• Review and approve work orders and job plans within Maximo.
• Review GMP documentation, including logbooks, electronic and paper forms, pest-control documentation, and related reports.
• Review and approve Manufacturing Execution System (MES) records, including electronic batch records.
• Support the management and oversight of rejected materials.
• Review and approve DeltaV audit trail entries.
• Ensure deviations from established procedures are properly documented and handled according to approved quality processes.
• Collaborate cross-functionally to ensure quality-related activities and assigned tasks are completed accurately and on time.
• Proactively identify and escalate potential quality, compliance, or safety risks.
• Maintain required training and documentation to ensure continued compliance.
• Spend approximately 25% of the shift in cleanroom environments, following appropriate gowning and aseptic practices.

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biotechnology, Engineering, or a related field.
• Minimum of 2 years of experience in Quality or Manufacturing within a regulated environment.
• Strong understanding of cGMP principles and regulatory requirements.
• Experience reviewing GMP documentation, manufacturing records, deviations, work orders, or quality records.
• Experience with systems such as Maximo, MES, Veeva Vault, or similar quality/manufacturing systems preferred.
• Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and Teams.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across Quality, Manufacturing, Engineering, and other technical teams.
• Ability to prioritize multiple responsibilities and make sound decisions in a fast-paced environment with limited oversight.

Schedule

100% onsite, Monday–Friday, 8:30 AM–5:00 PM or 6:30 AM–3:00 PM with a 30‑minute meal break. Contract length: 12 months with potential for extension. Location: West Greenwich, RI.

Pay

$25.00–$30.00/hr. Individual compensation within this range depends on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan (pre‑tax and Roth post‑tax contributions available)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Eligibility requirements apply to some benefits and may depend on job classification and length of employment; benefits are subject to change.

Application deadline: November 25, 2026.