Scientist - Quality Control (QC)

Scientist – Quality Control (QC) at Ardena 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. Location: Somerset, New Jersey FLSA Status: Exempt Employment Type: Full‑Time Key Responsibilities Perform analytical testing of raw materials, in-process materials, finished products, and stability samples. 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: High Performance Liquid Chromatography (HPLC/LC) Gas Chromatography (GC) Dissolution Testing 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 SOPs. Collaborate with cross‑functional teams to ensure project objectives and customer timelines are achieved. Support Quality Systems and laboratory infrastructure initiatives. 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 manage multiple priorities while meeting project deadlines. Fluent 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 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 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 Ardena offers an international working environment that encourages development, ownership, and career growth across functions and locations. Benefits include: 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. 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. #J-18808-Ljbffr Ardena Careers