Commercial Quality Control Chemist I

Duties & Responsibilities • Perform routine and non-routine analytical testing of commercial pharmaceutical products in accordance with approved analytical methods, specifications, SOPs, and laboratory procedures.

• Execute facility testing, finished product release, stability, in-process control, raw material, and other QC testing as assigned.

• Operate applicable laboratory instrumentation and perform analytical techniques, including HPLC, GC, dissolution, UV-Vis, FTIR, and other technologies as qualified.

• Prepare samples, standards, reagents, and solutions in accordance with approved procedures.

• Accurately calculate, document, and report analytical results within established testing timelines.

• Adhere to cGMP laboratory standards, Good Documentation Practices (GDocP), data integrity principles, and applicable regulatory requirements.

• Complete laboratory documentation ensuring accuracy and completeness.

• Review analytical data and supporting documentation for accuracy, completeness, and compliance with approved procedures.

• Maintain a clean, organized, and safe laboratory environment while following applicable safety and chemical hygiene procedures.

• Participate in investigations related to laboratory incidents, deviations, OOS, OOT, and other unexpected analytical results.

• Assist with root cause investigations and implementation of corrective and preventive actions (CAPAs) as assigned.

• Support analytical method transfers and method verification activities as assigned.

• Participate in laboratory training programs and maintain required training and qualification records.

• Support laboratory continuous improvement initiatives to improve testing efficiency, accuracy, compliance, and right-first-time execution.

• Assist in client inquiries, regulatory inspections, audits, and other QC activities as requested by QC management.

Required Skills & Abilities • Strong understanding of cGMP laboratory practices and applicable regulatory expectations.

• Knowledge of Good Documentation Practices (GDocP) and data integrity principles.

• Working knowledge of analytical chemistry principles, laboratory techniques, and pharmaceutical testing practices.

• Demonstrated ability to accurately execute analytical methods and laboratory procedures.

• Strong mathematical, analytical, and problem-solving skills.

• Ability to interpret analytical results and identify atypical or unexpected data.

• Excellent attention to detail and organizational skills.

• Excellent time management skills with the ability to meet testing deadlines and commercial manufacturing schedules.

• Ability to prioritize multiple tasks in a fast-paced laboratory environment.

• Demonstrated ability to collaborate and work effectively in cross-functional teams.

• Excellent verbal and written communication skills.

• Ability to communicate analytical results, testing status, and laboratory concerns effectively.

• Ability to follow written procedures and work independently with appropriate oversight.

• Ability to accept feedback, adapt to changing priorities, and constructively manage conflict.

Education & Experience • Bachelor’s degree in a scientific discipline or related field, with 1- 2 years of hands-on lab experience preferred; or

• Master’s degree in a scientific discipline or related field, with 1 year of hands-on lab experience preferred.

• Experience in pharmaceutical commercial QC testing preferred.

Physical Requirements • Prolonged periods of sitting or standing at a desk and working on a computer.

• Must be able to lift up to 25 pounds at times.

• Adheres to consistent and predictable in-person attendance.