Scientist; Stability & References

Scientist (Stability & References)

Kelly Science has an opening for a Scientist for a long-term engagement at one of our Global consumer products clients in Summit NJ. The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, 401K, and annual performance reviews. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

This client is a company leading the way in consumer products.

Schedule: Monday-Friday, Day Shift

Compensation: $35-50 an hour

Note :
This site is BYOD and candidates are required to supply their own laptop

The Stability Testing & Reference Standards Laboratory Specialist is responsible for supporting the planning, execution, documentation, review, and data management activities associated with stability testing and reference standard programs. This role provides laboratory and LIMS support to ensure stability samples and reference standards are tested according to approved protocols, methods, specifications, schedules, and applicable GMP requirements.

The position will work closely with Quality, Laboratory, Stability, and other cross-functional stakeholders to ensure timely and compliant execution of testing activities, accurate laboratory documentation, appropriate investigation of laboratory events, and reliable data trending.

The individual will be expected to operate in a highly regulated laboratory environment and demonstrate strong attention to detail, sound analytical judgment, data integrity awareness, and adherence to laboratory safety requirements.

• Perform chemical and physical testing of raw materials, including scheduling, execution, and review of stability and reference standard testing in accordance with USP/NF, EP, and internal guidelines.
• Ensure the accuracy and completion of all raw material and stability sample testing activities, including pulling samples from chambers and maintaining associated Laboratory Information Management System (LIMS) records (entry, verification, approval, and data trending).
• Review technical documentation such as laboratory notebooks, protocols, chromatography reports, and all testing results to ensure alignment with supplier specifications and compliance with standards.
• Conduct thorough laboratory investigations and prepare Laboratory Investigation Reports (LIR) in accordance with company and regulatory oversight.
• Comply with cGMP requirements, become familiar with Standard Operating Procedures (SOPs), applicable Quality Standards, Work Instructions, and operational guidance to ensure best practices in laboratory operations.
• Maintain a safe and compliant laboratory environment by attending required safety trainings and adhering to all safety protocols.

• Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline;
  Master’s degree preferred
• 3–7+ years of experience in a pharmaceutical, biotechnology, consumer health, or other regulated laboratory environment with direct hands‑on experience in analytical laboratory testing within a GMP environment.
• Demonstrated expertise and hands‑on experience with analytical techniques, including HPLC, GC, FT-IR, UV/VIS, wet chemistry, and related instrumentation common to the pharmaceutical industry.
• Working knowledge of regulatory requirements, including ICH, FDA, and major compendia (USP, JP, EP).
• Strong oral and written communication skills, with experience reviewing analytical laboratory documentation and chromatographic data.

• Proficient in the use of chromatographic data acquisition systems (e.g., Empower), Laboratory Information Management Systems (LIMS), Microsoft Word, and Microsoft Excel; experience with Documentum-based document storage systems and other laboratory informatics systems highly preferred.
• Experience in stability testing and/or reference standard programs strongly preferred.
• Experience performing or supporting laboratory investigations, deviations, OOS/OOT assessments, or similar quality…