Quality Assurance Senior Associate; GMP​/Floor

Quality Assurance Senior Associate (GMP/Floor)

In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on-the-floor quality oversight for Facilities and Engineering (F&E), Process Development, Incoming Quality Assurance (IQA), and Manufacturing operations. The position requires close collaboration with cross‑functional teams to ensure that all activities within bulk drug substance operations 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, and periodic pest control (monthly/quarterly) reports, RT reports, and other GMP documentation.
• Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
• Handle reject materials.
• Document deviations from established procedures according to approved processes.
• Communicate and collaborate effectively across departments to ensure completion of assigned tasks.
• Complete required training assignments to maintain compliance and readiness for task execution.
• Proactively identify and elevate quality, compliance, or safety risks to management.
• Maintain a presence in cleanroom areas (~25% of shift time), including proper gowning and adherence to aseptic practices.

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

• High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Master’s Degree.

• Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast‑paced environment.
• Exposure to F&E operations (including documentation, both paper based and Electronic).
• GMP experience (MFG, Quality, or F&E).

Location:

West Greenwich, RI