Senior Quality Assurance Specialist

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.

We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.

If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
 

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

WHAT YOU WILL WORK ON

YOUR ROLE

The Senior Quality Assurance Specialist supporting Manufacturing, Warehouse, Engineering, Analytical Services, Supply Chain and other site 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 can interact with all levels of management and all departments.

YOUR KEY RESPONSIBILITIES

• 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 checks define by the procedures.
• Execution, review, approval and maintaining QA department logbooks as per SOP example but not limited to QA HOLD, Rejection, PBR tracker etc.
• Audit of raw materials, warehouse, and facility logs.
• Review and approval of Cleaning Batch Records (CBR) and Production Batch Records (PBR).
• Review and approval of Master Batch Record (MBR).
• 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. 
• Provide coaching, guidance, and training for employees.
• Participate in activity regulatory, customer, and internal audits.
• 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.
• Review and approval of the site's documents from the quality site as an example but limited protocol, validation report, equipment qualification etc.
• Actively participate in any process associated with continues improvement program.
• 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 R