Quality Assurance Senior Associate

Target PR:

19-27/hr

DOE 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 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.

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.