Quality Assurance Senior Associate

Fives DyAG Corp.; West Greenwich (RI); On-site; USD 70,000 - 110,000; Full time

Job summary

Fives DyAG Corp. in West Greenwich, RI, seeks a Plant Quality Assurance professional to provide on-the-floor quality oversight across F&E, PD, IQA, and Manufacturing operations.

The role ensures cgMP adherence and regulatory compliance through rigorous documentation and cross-functional collaboration. The position requires 2+ years in Quality or Manufacturing, a Life Sciences degree, and strong experience with Maximo, MES, and Veeva Vault.

Qualifications

• Bachelor's degree in life sciences or related field.
• 2+ years in Quality or Manufacturing with exposure to F&E activities.

Responsibilities

• Provide on-the-floor quality oversight for F&E, IQA, PD, and Manufacturing to ensure cgMP compliance.
• Review and approve work orders, logbooks, and MES records (EBRs/ESPs).
• Maintain cleanroom presence (~25% of shift) with proper gowning and aseptic practices.
• Collaborate across PQA, PD, IQA, F&E, and Manufacturing to complete tasks and training.

Skills

cGMP knowledge

Quality oversight

Maximo usage

MS Office

Education

Bachelor's Degree in Life Sciences

Tools

Maximo

OEFM

MES

Veeva Vault

Job description

Note

100% onsite ARI. Location: Onsite – West Greenwich, RI. Schedule: Administrative Shift | 6:45 AM – 3:15 PM (with 30 minute meal break). Contract Length: 12 months with potential for extension.

Position Overview

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 uplift 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

• • Bachelor's 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.

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