Senior Quality Assurance Associate – cGMP Manufacturing

Us Tech Solutions; West Greenwich (RI); On-site; USD 37,000 - 38,000; Full time

Job summary

Us Tech Solutions in West Greenwich, RI is seeking a Plant Quality Assurance professional to provide on-the-floor quality oversight for Facilities and Engineering, Process Development, IQA, and Manufacturing operations. The role requires close collaboration with cross-functional teams to ensure bulk drug substance operations meet cGMP and regulatory requirements.

The position emphasizes expertise with enterprise systems such as Maximo, OEFM, MES, and Veeva Vault, adherence to aseptic practices

Qualifications

• Bachelor’s Degree in 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.

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 elevate 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.

Skills

Prioritize & navigate ambiguity

Cross-functional collaboration

GMP experience

Education

Bachelor’s Degree in Life Sciences

Tools

Maximo

OEFM

MES

Veeva Vault

Job description

Us Tech Solutions in West Greenwich, RI is seeking a Plant Quality Assurance professional to provide on-the-floor quality oversight for Facilities and Engineering, Process Development, IQA, and Manufacturing operations. The role requires close collaboration with cross-functional teams to ensure bulk drug substance operations meet cGMP and regulatory requirements.

The position emphasizes expertise with enterprise systems such as Maximo, OEFM, MES, and Veeva Vault, adherence to aseptic practices