Senior QA Associate - Plant

GTT•West Greenwich, RI

5d•Onsite

About The Position

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. This 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.

Requirements

Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment.
Experience collaborating within and across functional areas, with a strong focus on customer service and partnership.
GMP experience (either MFG or QA).
High school diploma / GED + 4 years of work experience, OR Associate degree + 2 years of work experience, OR Bachelor's degree + 6 months of work experience, OR Master's degree
Minimum of 2 years of experience in Quality or Manufacturing, with exposure to F&E-related activities (preferred).

Nice To Haves

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.
Demonstrated ability to make sound decisions in a dynamic, fast-paced environment.
Bachelor's degree in a relevant field (e.g., Life Sciences) preferred.

Responsibilities

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.
Handling of rejected 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, F&E, 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.