Quality Assurance Senior Associate

About the role

This is a contract position (12 months with potential for extension) based onsite in West Greenwich, RI. In this critical role you will serve as a Plant Quality Assurance (PQA) professional providing on-the-floor quality oversight for Facilities and Engineering (FE), Process Development, Incoming Quality Assurance (IQA) and Manufacturing operations. You will collaborate with cross‑functional teams to ensure that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements.

Responsibilities

• Provide quality oversight for FE, 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.
• Review/Approve Delta V Audit Trail entries.
• Ensure that any deviations from established procedures are properly documented according to approved processes.
• Communicate and collaborate effectively across departments PQA, PD, IQA, FE and Manufacturing to ensure completion of assigned tasks.
• Complete required training assignments to maintain compliance and readiness for task execution.
• Proactively identify and escalate 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.

Qualifications

• Bachelor’s Degree in a relevant field (e.g., Life Sciences).
• Minimum of 2 years of experience in Quality or Manufacturing with exposure to FE‑related activities.
• Strong understanding of cGMP principles and regulatory expectations.
• Demonstrated experience utilizing enterprise systems such as Maximo, OEFM, MES and Veeva Vault CDOCS/DQMS to support quality oversight documentation management and manufacturing execution processes.
• Proficient in Microsoft Office applications including Outlook, Word, Excel, PowerPoint and 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‑p