About this role
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.