Quality Assurance Senior Associate

Plant Quality Assurance (PQA) Associate

Base Pay Range: $30.00 - $32.00/hr

Summary: In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on‑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.

• 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, periodic pest control reports, RT reports, and other GMP documentation.
• Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
• Handle rejected materials.
• Review and approve Delta V Audit Trail entries.
• Document deviations from established procedures 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.

• 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 with enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight, documentation management, and manufacturing execution processes.
• Proficiency 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.

• Prioritization and navigation of ambiguity with minimal oversight in a fast‑paced environment.
• Exposure to F&E operations and documentation (paper‑based and electronic).
• GMP experience (MFG, Quality, or F&E).

Seniority Level: Entry level

Employment Type:

Contract

Job Function:
Quality Assurance

The typical base pay for this role across the U.S. is $30.00 - $32.00/hour
. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience.

Full‑time employees are eligible to select from different benefits packages which may include medical, dental, and vision benefits; health savings accounts; paid time off; bereavement leave; 401(k) plan participation with employer match; life and disability insurance; commuter benefits; flexible spending accounts; accident insurance; critical illness insurance; hospital indemnity insurance; accommodations; work travel reimbursement; discretionary performance or recognition bonus; sick leave and mobile phone reimbursement provided based on state or local law.

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