Quality Assurance Senior Associate

Planet Pharma; West Greenwich (RI); On-site; USD 26,174 - 37,195; Full time

Job summary

Planet Pharma is seeking a Plant Quality Assurance (PQA) professional in West Greenwich, Rhode Island. In this role, you'll oversee quality for Facilities and Engineering, ensuring compliance with cGMP and regulatory requirements.

Key responsibilities include reviewing logs, handling reject materials, and ensuring team collaborations for task completions. A Bachelor’s Degree and 2 years of experience are required, along with strong communication and problem-solving skills.

Qualifications

• 2+ years of experience in Quality or Manufacturing.
• Understanding of regulatory expectations.
• Strong communication skills.

Responsibilities

• Provide quality oversight for F&E and IQA Warehouse areas.
• Ensure compliance with cGMP standards.
• Collaborate effectively across departments.
• Complete required training assignments.

Skills

Quality oversight

cGMP principles

Communication skills

Problem-solving

Education

Bachelor’s Degree in a relevant field

Tools

Maximo

Microsoft Office

Job description

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.

Target PR: 19-27/hr DOE

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 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 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.