Ardena
Join to apply for the Senior Quality Assurance Specialist role at 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.
For the Ardena Business Unit based in Somerset (US), we are looking for a Senior Quality Assurance Specialist.
Your Role The Senior Quality Assurance Specialist supports 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 in a fast‑paced environment, possess good 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.
Perform Line Clearances, equipment releases and AQL inspections, and in‑process checks of manufacturing processes and other quality checks defined by the procedures.
Execute, review, approve and maintain QA department logbooks per SOP, including QA HOLD, Rejection, PBR tracker, etc.
Audit raw materials, warehouse, and facility logs.
Review and approve Cleaning Batch Records (CBR) and Production Batch Records (PBR).
Review and approve Master Batch Record (MBR).
Assist with quality systems record quality review and closure: deviation, complaint, change control, OOS/OOT, etc.
Host routine Change Control committee, Deviation Review Committee (DRC) and Root cause/CAPA meetings.
Review repaired equipment work orders for quality/compliance impact assessment.
Create, revise and approve site SOPs.
Provide coaching, guidance, and training for employees.
Participate in regulatory, customer, and internal audits.
Participate in site non‑conformance investigation as QA representative.
Support site on quality review and approval of record closures: deviation, change control, complaint, etc.
Review site documents: protocol, validation report, equipment qualification, etc.
Actively participate in continuous improvement programs.
Review analytical department documents: CoA, stability report, method validation, protocol, micro report, etc.
Perform annual retain‑sample inspection.
Issue and reconcile CBRs and PBRs.
Approve/reject final batch disposition release decisions.
Review and approve raw material releases.
Communicate interdepartmentally to obtain information.
Support audit activities: regulatory, customer, internal, etc.
Address customer quality observations and participate in customer calls as quality representative.
Ensure compliance with Health, Safety, and Environmental responsibilities.
Assist with quality event processes and batch investigations as required.
Work flexible shifts as required.
Work weekend support and extra hours on weekdays as required.
Perform other duties assigned by a manager.
Physical Requirements
Ability to walk, sit and 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.
Ability to work wearing Personal Protective Equipment (PPE) such as eyeglasses, respirator, etc.
Ability to work under pressure to meet deadlines; be accessible to laboratory, pilot plant areas and office staff; specific vision requirements include reading written documents and frequent use of computer monitor screen; ability to lift 10‑15 pounds.
Your Profile
Minimum bachelor’s degree or higher equivalent with 3+ years of relevant experience in Quality Assurance, Compliance, or Manufacturing in the pharma industry.
Good understanding of compliance, regulations and inspection techniques; thorough knowledge of cGMP, ability to evaluate facility records, processes, procedures and practices for conformance.
Knowledge of FDA, cGMP and DEA regulations pertaining to Pharmaceutical Development.
Detail oriented with effective oral and written communication, team oriented with interpersonal skills.
Ability to work under high pressure with multiple project deadlines.
Soft skills aligned with Ardena’s CARE values: Communicative, Accountable, Reliable, and Excellent.
What 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!
#J-18808-Ljbffr
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.
For the Ardena Business Unit based in Somerset (US), we are looking for a Senior Quality Assurance Specialist.
Your Role The Senior Quality Assurance Specialist supports 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 in a fast‑paced environment, possess good 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.
Perform Line Clearances, equipment releases and AQL inspections, and in‑process checks of manufacturing processes and other quality checks defined by the procedures.
Execute, review, approve and maintain QA department logbooks per SOP, including QA HOLD, Rejection, PBR tracker, etc.
Audit raw materials, warehouse, and facility logs.
Review and approve Cleaning Batch Records (CBR) and Production Batch Records (PBR).
Review and approve Master Batch Record (MBR).
Assist with quality systems record quality review and closure: deviation, complaint, change control, OOS/OOT, etc.
Host routine Change Control committee, Deviation Review Committee (DRC) and Root cause/CAPA meetings.
Review repaired equipment work orders for quality/compliance impact assessment.
Create, revise and approve site SOPs.
Provide coaching, guidance, and training for employees.
Participate in regulatory, customer, and internal audits.
Participate in site non‑conformance investigation as QA representative.
Support site on quality review and approval of record closures: deviation, change control, complaint, etc.
Review site documents: protocol, validation report, equipment qualification, etc.
Actively participate in continuous improvement programs.
Review analytical department documents: CoA, stability report, method validation, protocol, micro report, etc.
Perform annual retain‑sample inspection.
Issue and reconcile CBRs and PBRs.
Approve/reject final batch disposition release decisions.
Review and approve raw material releases.
Communicate interdepartmentally to obtain information.
Support audit activities: regulatory, customer, internal, etc.
Address customer quality observations and participate in customer calls as quality representative.
Ensure compliance with Health, Safety, and Environmental responsibilities.
Assist with quality event processes and batch investigations as required.
Work flexible shifts as required.
Work weekend support and extra hours on weekdays as required.
Perform other duties assigned by a manager.
Physical Requirements
Ability to walk, sit and 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.
Ability to work wearing Personal Protective Equipment (PPE) such as eyeglasses, respirator, etc.
Ability to work under pressure to meet deadlines; be accessible to laboratory, pilot plant areas and office staff; specific vision requirements include reading written documents and frequent use of computer monitor screen; ability to lift 10‑15 pounds.
Your Profile
Minimum bachelor’s degree or higher equivalent with 3+ years of relevant experience in Quality Assurance, Compliance, or Manufacturing in the pharma industry.
Good understanding of compliance, regulations and inspection techniques; thorough knowledge of cGMP, ability to evaluate facility records, processes, procedures and practices for conformance.
Knowledge of FDA, cGMP and DEA regulations pertaining to Pharmaceutical Development.
Detail oriented with effective oral and written communication, team oriented with interpersonal skills.
Ability to work under high pressure with multiple project deadlines.
Soft skills aligned with Ardena’s CARE values: Communicative, Accountable, Reliable, and Excellent.
What 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!
#J-18808-Ljbffr