Chemist

The Associate Scientist performs routine analytical testing on a wide range of pharmaceutical samples including finished products, stability samples, raw materials, process validation samples, and developmental samples within an FDA- and GMP-regulated laboratory. Using techniques such as UV-Vis and HPLC, this role evaluates test results, determines sample acceptability, and maintains complete and accurate documentation in compliance with SOPs and cGMP standards.

The position supports both first and second shift operations, with all training conducted on first shift.

• Perform routine testing of finished products, stability samples, raw materials, in-process and process validation samples, CV samples, and developmental samples in a regulated laboratory environment.
• Conduct assays, chromatographic purity tests, content uniformity analyses using UV-Vis and HPLC, particle size distribution measurements using various techniques, and water determination by Karl Fischer, following in-house monographs and USP methods.
• Evaluate test results and decide on the acceptability of samples based on established criteria and analytical outcomes.
• Maintain accurate laboratory notebooks and complete all related analytical reports, summaries, and documentation in strict compliance with SOPs.
• Ensure laboratories are maintained with good housekeeping practices and remain in full compliance with cGMP requirements.
• Review laboratory notebooks promptly to ensure completeness, accuracy, and adherence to SOPs.
• Analyze and interpret data and test results, and communicate findings clearly in both written and oral formats.
• Assist in training new analysts by demonstrating laboratory techniques, explaining procedures, and reinforcing compliance with SOPs and cGMP.
• Conduct laboratory investigations as needed and initiate Quality Events, CAPA (Corrective and Preventive Actions), and Change Controls in accordance with quality system procedures.
• Follow all SOPs and safety guidelines to maintain a safe working environment and ensure ongoing compliance with FDA and GMP regulations.
• Aid in the writing of laboratory-related documentation, such as reports and procedural summaries, to support analytical and quality activities.

• Bachelors degree in Chemistry or a related scientific field with 12 years of related experience in pharmaceutical analysis, or a Masters degree in Chemistry or a related scientific field with 1 year of related experience in pharmaceutical analysis.
• Proficiency in HPLC techniques for pharmaceutical analysis.
• Proficiency in UPLC methods and related chromatographic techniques.
• Strong working knowledge of UV-Vis spectroscopy for routine testing.
• Solid analytical experience in chemistry, with the ability to apply principles to pharmaceutical testing.
• Familiarity with FDA regulations and GMP requirements for laboratory operations.
• Ability to solve problems involving several concrete variables in standardized situations.
• Ability to perform necessary computations and to draw and interpret graphs related to analytical data.
• Working knowledge of instrumentation software commonly used in analytical laboratories.
• Attention to detail and strong documentation skills to support accurate recordkeeping and reporting.
• Capability to collaborate with colleagues and contribute to training and knowledge sharing within the lab team.

This role is based in an FDA- and GMP-regulated laboratory environment focused on pharmaceutical analysis. Work is performed using analytical instruments such as HPLC, UPLC, UV-Vis spectrophotometers, and other equipment required for particle size distribution and water determination testing. The position operates on either first shift (typically 8:00 a.m. to 5:00 p.m.) or second shift (typically 2:00 p.m. to 11:00 p.m.), with all training conducted during first shift hours.

The lab emphasizes strict adherence to SOPs, cGMP standards, safety guidelines, and good housekeeping practices, providing a structured, process-oriented setting for scientific work.

This is a Contract to Hire position based out of Deerfield Beach, FL.

The pay range for this position is $29.00 - $39.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job…