Senior Quality Assurance Associate

Senior Quality Assurance Associate

Planet Pharma

In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on‑the‑floor quality oversight for Facilities & Engineering (F&E), Process Development, Incoming Quality Assurance (IQA), and Manufacturing operations. You will collaborate closely with cross‑functional teams to ensure all bulk drug substance activities adhere to cGMP and other regulatory requirements.

• Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the Raw Material Sampling Lab), and Process Development Laboratories.
• Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and other applicable regulatory requirements.
• Review and approve work orders and job plans within Maximo.
• Review logbooks (paper‑based and electronic), particle‑generating forms, pest control sighting forms, periodic pest control reports, RT reports, and other GMP documentation.
• Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
• Handle reject materials.
• Review/Approve Delta V Audit Trail entries.
• Ensure deviations from established procedures are documented per approved processes.
• Communicate and collaborate across departments (PQA, PD, IQA, F&E, and Manufacturing) to ensure task completion.
• Complete required training assignments to maintain compliance and readiness.
• Proactively identify and elevate quality, compliance, or safety risks to management.
• Maintain a presence in cleanroom areas (~25% of shift time), following proper gowning and aseptic practices.

• Bachelor’s Degree in a relevant field (e.g., Life Sciences).
• Minimum 2 years of experience in Quality or Manufacturing, with exposure to F&E‑related activities.
• Strong understanding of cGMP principles and regulatory expectations.
• Experience using enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS).
• Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Teams).
• Excellent written and verbal communication skills.
• Experience collaborating across functional areas with a focus on customer service and partnership.
• Ability to make sound decisions in a dynamic, fast‑paced environment.
• Ability to prioritize and navigate ambiguity with minimal oversight.

Salary: $23–$33 per hour (depending on experience)

Seniority level:
Not Applicable

Employment type:

Full‑time

Job function:
Quality Assurance

Industries:
Staffing and Recruiting

Location:

West Greenwich, RI

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