Quality Control Chemist

Position Summary

Chemspec-API Inc. is seeking a motivated QC Chemist to join our Department of Quality Control in a cGMP-regulated pharmaceutical manufacturing environment. The successful candidate will perform routine and non-routine analytical testing to support the manufacture, release, and stability evaluation of active pharmaceutical ingredients (APIs). This position offers an excellent opportunity to develop technical expertise while working with modern analytical instrumentation and collaborating with cross-functional teams in Quality Assurance, Manufacturing, and R&D.

Key Responsibilities

• Perform routine analytical testing of raw materials, starting materials, intermediates, APIs, and stability samples using validated analytical methods.
• Operate analytical instrumentation including HPLC, GC, UV-Vis spectroscopy, pH meters, Karl Fischer titration, potentiometric titration, TLC, and other laboratory equipment.
• Conduct raw material, in-process, finished product, and stability testing in accordance with approved procedures and cGMP requirements.
• Prepare reagents, standards, mobile phases, and laboratory solutions as required.
• Accurately document analytical results in laboratory notebooks, worksheets, and electronic systems in compliance with cGMP and data integrity requirements.
• Maintain, calibrate, and perform routine troubleshooting of laboratory instruments in accordance with SOPs.
• Support analytical method verification, validation, transfer, and investigations, as assigned.
• Assist with laboratory housekeeping, inventory management, and maintenance of laboratory supplies.
• Collaborate with Manufacturing, QA, and R&D to support production activities, process development, and special analytical projects.
• Follow all company safety policies, cGMP regulations, SOPs, and applicable ICH and FDA guidelines.
• Perform other duties as assigned by management.

Qualifications

Education

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.

Experience

• 0–5 years of laboratory experience in the pharmaceutical, biotechnology, or chemical industry.
• Recent graduates with strong laboratory experience are encouraged to apply.

Technical Skills

• Hands-on experience with analytical techniques such as:
• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• UV-Visible Spectroscopy
• Potentiometric Titration
• Karl Fischer Titration
• Thin-Layer Chromatography (TLC)
• General wet chemistry techniques
• Familiarity with cGMP regulations, ICH guidelines, Good Documentation Practices (GDP), and laboratory data integrity principles is preferred.
• Experience with analytical method execution and laboratory instrumentation maintenance is desirable.

Required Competencies

• Strong attention to detail and commitment to producing high-quality analytical data.
• Excellent written and verbal communication skills.
• Strong organizational and time-management skills with the ability to manage multiple priorities.
• Ability to work independently as well as collaboratively in a team-oriented environment.

Pay: From $58,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Work Location: In person