Scientist – Quality Control (QC)

About the role

The Ardena Group is seeking a Scientist – Quality Control (QC) to join our Quality Control team in Somerset, NJ. This role supports pharmaceutical development and commercial manufacturing by performing analytical testing of raw materials, in-process materials, finished products, and stability samples within a GMP-regulated laboratory environment.

Role Description

This position offers the opportunity to contribute directly to the quality, safety, and timely release of pharmaceutical products supporting patients worldwide. As a Scientist – Quality Control (QC), you will independently perform analytical testing and support quality control activities for clinical and commercial pharmaceutical products. You will analyze laboratory data, interpret results, investigate deviations, and communicate findings through technical reports and documentation.

Key Responsibilities

• Perform analytical testing of raw materials, in-process materials, finished products, and stability samples to support pharmaceutical development and commercial manufacturing.
• Independently execute laboratory testing with accuracy while maintaining complete and compliant documentation.
• Analyze laboratory data, evaluate results for accuracy and integrity, and communicate findings through technical reports and presentations.
• Perform Quality Control activities required to meet project timelines and customer deliverables.
• Utilize analytical techniques including, but not limited to: High Performance Liquid Chromatography (HPLC/LC), Gas Chromatography (GC), Dissolution Testing, and Standard Wet Chemistry.
• Operate laboratory instrumentation and electronic systems including CDMS, LIMS, ELN, and other laboratory software.
• Review analytical data for completeness, accuracy, and compliance with regulatory and data integrity requirements.
• Conduct and document laboratory investigations, deviations, and change management activities.
• Author and review analytical methods, protocols, reports, specifications, and Standard Operating Procedures (SOPs).
• Collaborate with cross-functional teams to ensure project objectives and customer timelines are achieved.
• Maintain compliance with cGMP, Health, Safety, Environmental, and Data Integrity requirements.
• Perform additional technical and administrative duties as assigned.

Profile & Qualifications

• Required Qualifications:
• Associate's degree in Chemistry or Analytical Chemistry with 5+ years of experience supporting pharmaceutical product development and manufacturing,
• or Bachelor's degree in Chemistry or Analytical Chemistry with 3+ years of experience supporting pharmaceutical product development and manufacturing.
• Experience working within a GMP-regulated pharmaceutical laboratory.
• Strong understanding of analytical chemistry principles and pharmaceutical Quality Control practices.
• Experience performing analytical testing using chromatographic and wet chemistry techniques.
• Proficiency with analytical instrumentation, including LC (HPLC), GC, and Dissolution systems.
• Experience using laboratory electronic systems such as CDMS, LIMS, and Electronic Laboratory Notebooks (ELN).
• Strong organizational, analytical, and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to effectively manage multiple priorities while meeting project deadlines.
• Fluency in English, both written and spoken.
• Preferred Qualifications:
• Experience supporting pharmaceutical development and commercial manufacturing environments.
• Working knowledge of cGMP, FDA regulations, and data integrity requirements.
• Experience authoring or reviewing SOPs, analytical methods, laboratory investigations, deviations, and technical reports.
• Proficiency with Microsoft Office applications, including Teams, Word, Excel, and PowerPoint.
• Experience working collaboratively with cross-functional technical teams.
• Alignment with Ardena's CARE values: Communicative, Accountable, Reliable, and Excellent.

Physical Requirements

• Ability to occasionally lift up to 15 pounds.
• Ability to work within laboratory, manufacturing, and office environments.
• Frequent use of computers and laboratory instrumentation.
• Ability to read and interpret technical documentation.
• Must be capable of wearing required Personal Protective Equipment (PPE), including safety glasses, respirators (when required), and safety shoes.
• Must successfully complete required safety and OSHA training, including respirator fit testing.
• Ability to work in temperature- and humidity-controlled laboratory environments.

What Ardena Offers

• Competitive salary and comprehensive benefits package.
• Paid time off and company-recognized holidays.
• Medical, dental, vision, life, and disability insurance.
• 401(k) retirement savings plan with company match.
• Professional development and training opportunities.
• A collaborative international work environment across Europe and the United States.
• Opportunities to contribute to innovative pharmaceutical development projects that improve patient health.
• A values-driven culture guided by Ardena's CARE principles: Communicative, Accountable, Reliable, and Excellent.

How to Apply

Ready to advance your career in pharmaceutical Quality Control? Apply today through the Ardena Careers website at careers.ardena.com and become part of a team dedicated to advancing pharmaceutical innovation and improving patient lives worldwide.