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Quality Assurance Senior Associate #26-23765

Job Location:

West Greenwich, RI - USA

Hourly Salary: USD 27 - 27

Posted: 20 September 2026 (7 hours ago)

Application Deadline: 18 December 2026

Vacancies: 1 Vacancy

Duration:12months contract
Schedule: 6:45 AM 3:15 PM (with 30-minute meal break)

Summary:

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.

Key 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 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 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.

Preferred Qualifications:

Bachelors Degree in a relevant field (e.g. Life Sciences)
Minimum of 2 year of experience in Quality or Manufacturing with exposure to F&E-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-paced environment.
Ability to prioritize and navigate ambiguity with minimal oversight in a fast-paced environment.

Must Have Skill Sets:

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)