Quality Assurance Senior Associate (GMP/Floor)

Infotree Global Solutions; West Greenwich (RI); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading pharmaceuticals company seeks a Quality Assurance Senior Associate in West Greenwich, RI. In this role, you will provide crucial quality oversight for manufacturing operations and ensure compliance with regulatory standards. Responsibilities include reviewing quality documentation, collaborating with various departments, and maintaining GMP practices. Ideal candidates have a Bachelor's degree, at least 2 years of relevant experience, and familiarity with industry systems. This position offers opportunities for growth in a dynamic environment.

Qualifications

• Minimum of 2 years of experience in Quality or Manufacturing.
• Strong understanding of cGMP principles and regulatory expectations.
• Experience utilizing enterprise systems like Maximo and MES.

Responsibilities

• Provide quality oversight for F&E and IQA Warehouse areas.
• Ensure facilities comply with cGMP standards.
• Review and approve work orders and job plans.

Skills

Ability to prioritize and navigate ambiguity

Exposure to F&E operations

GMP experience

Strong communication skills

Proficient in Microsoft Office

Education

Bachelor's Degree in a relevant field

Tools

Maximo

MES

Job description

Quality Assurance Senior Associate (GMP/Floor)

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. The 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.
• Handle reject materials.
• Document deviations from established procedures according to approved processes.
• Communicate and collaborate effectively across departments 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.

Preferred Qualifications

• Bachelor’s Degree in a relevant field (e.g., Life Sciences).
• Minimum of 2 years of experience in Quality or Manufacturing, with exposure to F&E‑related activities.
• Strong understanding of cGMP principles and regulatory expectations.
• Experience utilizing enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS).
• Proficient in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, 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.

Basic Qualifications

• High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Master’s Degree.

Top 3 Must Have Skill Sets

• Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast‑paced environment.
• Exposure to F&E operations (including documentation, both paper based and Electronic).
• GMP experience (MFG, Quality, or F&E).

Location: West Greenwich, RI