Senior QA Associate - PQA

QA Senior Associate - PQA

Location: West Greenwich, RI

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 13 months
• Pay Rate: $24.00 $27.00 / Hour (USD)
• Shift / Schedule: Monday to Friday, Admin Shift | 8:30 AM 5:00 PM or 6:30 AM 3:00 PM (with 30-minute meal break)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job 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.
• Management and transport oversight 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.

Education Requirements

• 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 required.
• Bachelor's Degree in a relevant field (e.g., Life Sciences) preferred.

Required Experience

• Minimum of 2 years of experience in Quality or Manufacturing, with exposure to F&E-related activities.

Required Skills

• GMP / Life Sciences industry experience.
• Excellent written and verbal communication skills.
• Ability to coordinate and prioritize tasks in a fast-paced environment with minimal supervision.
• 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.
• 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.

Work Environment / Physical Requirements

• Must maintain a presence in cleanroom areas (~25% of shift time), including proper gowning and adherence to aseptic practices.

Important Notes

• Interview Process: One 30 45 minute interview with the hiring manager.

About GTT

GTT is an NMSDC-certified Minority Business Enterprise (MBE) headquartered in Portsmouth, New Hampshire. GTT is a subsidiary of Chenega Corporation, an Alaska-based company and one of the largest Alaska Native-owned corporations. An Inc. 5000 honoree and one of SIA's Best Staffing Firms to Work For, GTT connects professionals with Fortune 500 organizations across IT, engineering, construction, utilities, life sciences, financial services, and healthcare throughout the U.S. and Canada. We're committed to diverse, inclusive workplaces and to placing people in roles where they can do their best work.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Job Number: 26-18930 Industry: Manufacturing & Operations

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