Quality Assurance Operations Auditor

Overview

Introduction to Ardena. As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.

With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.

For the Ardena Business Unit based in Somerset (US), we are looking for a Quality Assurance Operations Auditor.

Quality Assurance Operations Auditor supports Manufacturing, Warehouse, Engineering, Analytical Services, Supply Chain and other departments as required. Candidate should have prior GMP inspection experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail oriented, able to multitask and work in a fast-paced multitask environment, possess good oral and written communication skills and have the ability to interact with all levels of management and all departments.

• Routine auditing of the Manufacturing Facility area to ensure compliance with cGMPS, DEA, FDA, and local site procedures.
• Provide QA support to manufacturing for clinical and commercial batches and other GMP activities.
• Performs Line Clearances, equipment releases and, AQL inspections, and in process checks of manufacturing processes and other quality check define by the procedures.
• Execution, review, approval and maintaining QA department logbooks as per SOP example but not limited to QA HOLD, Rejection, P  tracker etc.
• Audit of raw materials, warehouse, and facility logs.
• Review and approval of Cleaning Batch Records (C ) and Production Batch Records (P ).
• Review and approval of Master Batch Record (M ).
• Provide coaching, guidance, and training for employees.
• Assists with various quality systems record quality review and closure, like deviation, complaint, change control, OOS/OOT etc.
• Hosting routine Change Control committee, Deviation Review Committee (DRC) and Root cause/CAPA meetings.
• Review of equipment repaired workorder for quality/compliance impact assessment.
• Create, revision and approval of the site SOP.
• Participate in site non-conformance investigation as QA representative.
• Support site on quality review and approval of quality systems record closures an example deviation, change control, complaint etc.
• Actively participate in any process associated with continuing improvement program implementation at Somerset site level.
• Review and approval of analytical department document an example, CoA, Stability report, Method validation, protocol, Micro report etc.
• Performing annual Retain sample inspection.
• Issuance and reconciliation of CBRs and PBRs.
• Performing approval/rejection of final batch disposition release decision.
• Review, Approval, and Release of Raw Materials
• Interdepartmental communication for obtaining information.
• Supporting the various audit activities like regulatory, customer, internal etc., as necessary.
• Addressing the customer Quality observation.
• Comply with and ensure compliance of the department with Health, Safety, and Environmental responsibilities.
• Assist with quality event processes and batch investigations as required.
• Flexible working on different shifts as required.
• Weekend work to support manufacturing as required and working extra hours during weekdays as required.
• All other duties as assigned by a manager to support the department and business.

Education and Experience:
Minimu…