Ardena Careers
Join to apply for the
Senior Quality Assurance Specialist
role at
Ardena Careers
Introduction to Ardena
Ardena is a leading Contract Development and Manufacturing Organization (CDMO) that partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—to help biopharma innovators navigate drug development with precision, quality, and speed. 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 employs 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.
Senior Quality Assurance Specialist – Somerset (US) The Senior Quality Assurance Specialist supports Manufacturing, Warehouse, Engineering, Analytical Services, Supply Chain and other site departments as required. Candidates should have prior GMP inspection experience within a pharmaceutical manufacturing facility or equivalent. Candidates must be detail oriented, able to multitask in a fast‑paced environment, possess strong oral and written communication skills, and be able to 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.
Performance of Line Clearances, equipment releases, AQL inspections, and in‑process checks of manufacturing processes and other quality checks defined by the procedures.
Execution, review, approval and maintenance of QA department logbooks as per SOP (e.g., QA HOLD, Rejection, PBR tracker).
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).
Assist with various quality system record reviews and closures, such as deviation, complaint, change control, OOS/OOT.
Host routine Change Control Committee, Deviation Review Committee (DRC) and Root Cause/CAPA meetings.
Review of equipment repaired work orders for quality/compliance impact assessment.
Create, revise and approve site SOPs.
Provide coaching, guidance, and training for employees.
Participate in activity regulatory, customer, and internal audits.
Participate in site non‑conformance investigations as QA representative.
Support site on quality review and approval of quality system record closures (e.g., deviation, change control, complaint).
Review and approval of the site's documents from the quality site (e.g., limited protocol, validation report, equipment qualification).
Actively participate in any process associated with continuous improvement programs.
Review and approval of analytical department documents (e.g., CoA, Stability report, Method validation, protocol, micro report).
Perform annual Retain sample inspection.
Issue and reconcile CBRs and PBRs.
Perform approval/rejection of final batch disposition release decision.
Review, approval, and release of Raw Materials.
Inter‑departmental communication for obtaining information.
Support audit activities such as regulatory, customer, internal audits.
Address customer Quality observations and participate with the customer call as quality representative.
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 to work on different shifts as required.
Weekend work to support manufacturing as required and work extra hours during weekdays as required.
All other duties as assigned by a manager to support the department and business.
Physical Requirements
Walk, sit, stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch or crawl; talk and hear, smell and lift up to 40 pounds.
Work wearing Personal Protective Equipment (PPE) such as eyeglasses, respirator, etc.
Work effectively under pressure to meet deadlines; be accessible to laboratory and pilot plant areas and office staff and use required office equipment. Specific vision requirements include reading written documents and using a computer monitor screen frequently. Individuals may be required to lift 10–15 pounds.
Your Profile
A minimum bachelor's degree or higher equivalent with 3+ years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing.
Good understanding of compliance, regulations and inspection techniques. Thorough knowledge of cGMP, ability to evaluate facilities, records, processes, procedures and practices for conformance to these requirements.
Understanding of FDA, cGMP and DEA regulations pertaining to Pharmaceutical Development.
Detail oriented with effective oral and written communication skills, team oriented with effective interpersonal skills.
Ability to work effectively under high pressure with multiple project deadlines.
Soft skills that align with our CARE values – Communicative, Accountable, Reliable, and Excellent.
What We Offer At Ardena, we recognize that our people drive our success. We offer:
A competitive salary with a tailor‑made benefits package, including medical, dental and vision benefits effective day one of employment.
Salary Range: $80,000 - $95,000.
Paid Time Off.
A dynamic, global work environment with career growth opportunities.
Access to Ardena Academy, our internal learning platform for professional development.
A chance to contribute to groundbreaking drug development projects that make a real impact.
How To Apply Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!
Seniority level:
Mid‑Senior level
Employment type:
Contract
Job function:
Quality Assurance
Industries:
Pharmaceutical Manufacturing
Location:
Somerset, NJ
#J-18808-Ljbffr
Senior Quality Assurance Specialist
role at
Ardena Careers
Introduction to Ardena
Ardena is a leading Contract Development and Manufacturing Organization (CDMO) that partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—to help biopharma innovators navigate drug development with precision, quality, and speed. 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 employs 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.
Senior Quality Assurance Specialist – Somerset (US) The Senior Quality Assurance Specialist supports Manufacturing, Warehouse, Engineering, Analytical Services, Supply Chain and other site departments as required. Candidates should have prior GMP inspection experience within a pharmaceutical manufacturing facility or equivalent. Candidates must be detail oriented, able to multitask in a fast‑paced environment, possess strong oral and written communication skills, and be able to 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.
Performance of Line Clearances, equipment releases, AQL inspections, and in‑process checks of manufacturing processes and other quality checks defined by the procedures.
Execution, review, approval and maintenance of QA department logbooks as per SOP (e.g., QA HOLD, Rejection, PBR tracker).
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).
Assist with various quality system record reviews and closures, such as deviation, complaint, change control, OOS/OOT.
Host routine Change Control Committee, Deviation Review Committee (DRC) and Root Cause/CAPA meetings.
Review of equipment repaired work orders for quality/compliance impact assessment.
Create, revise and approve site SOPs.
Provide coaching, guidance, and training for employees.
Participate in activity regulatory, customer, and internal audits.
Participate in site non‑conformance investigations as QA representative.
Support site on quality review and approval of quality system record closures (e.g., deviation, change control, complaint).
Review and approval of the site's documents from the quality site (e.g., limited protocol, validation report, equipment qualification).
Actively participate in any process associated with continuous improvement programs.
Review and approval of analytical department documents (e.g., CoA, Stability report, Method validation, protocol, micro report).
Perform annual Retain sample inspection.
Issue and reconcile CBRs and PBRs.
Perform approval/rejection of final batch disposition release decision.
Review, approval, and release of Raw Materials.
Inter‑departmental communication for obtaining information.
Support audit activities such as regulatory, customer, internal audits.
Address customer Quality observations and participate with the customer call as quality representative.
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 to work on different shifts as required.
Weekend work to support manufacturing as required and work extra hours during weekdays as required.
All other duties as assigned by a manager to support the department and business.
Physical Requirements
Walk, sit, stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch or crawl; talk and hear, smell and lift up to 40 pounds.
Work wearing Personal Protective Equipment (PPE) such as eyeglasses, respirator, etc.
Work effectively under pressure to meet deadlines; be accessible to laboratory and pilot plant areas and office staff and use required office equipment. Specific vision requirements include reading written documents and using a computer monitor screen frequently. Individuals may be required to lift 10–15 pounds.
Your Profile
A minimum bachelor's degree or higher equivalent with 3+ years of relevant experience within the pharma industry in Quality Assurance, Compliance, or Manufacturing.
Good understanding of compliance, regulations and inspection techniques. Thorough knowledge of cGMP, ability to evaluate facilities, records, processes, procedures and practices for conformance to these requirements.
Understanding of FDA, cGMP and DEA regulations pertaining to Pharmaceutical Development.
Detail oriented with effective oral and written communication skills, team oriented with effective interpersonal skills.
Ability to work effectively under high pressure with multiple project deadlines.
Soft skills that align with our CARE values – Communicative, Accountable, Reliable, and Excellent.
What We Offer At Ardena, we recognize that our people drive our success. We offer:
A competitive salary with a tailor‑made benefits package, including medical, dental and vision benefits effective day one of employment.
Salary Range: $80,000 - $95,000.
Paid Time Off.
A dynamic, global work environment with career growth opportunities.
Access to Ardena Academy, our internal learning platform for professional development.
A chance to contribute to groundbreaking drug development projects that make a real impact.
How To Apply Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!
Seniority level:
Mid‑Senior level
Employment type:
Contract
Job function:
Quality Assurance
Industries:
Pharmaceutical Manufacturing
Location:
Somerset, NJ
#J-18808-Ljbffr