Job Description

SUMMARY:

The Sr. Quality Control Chemist will be responsible for conducting complex analytical testing of pharmaceutical raw materials and finished products, ensuring compliance with cGMP, FDA, and ICH guidelines. The role involves operating and troubleshooting laboratory instruments such as HPLC, GC, UV, and FTIR, as well as performing method validation, verification, and transfers. Additionally, the chemist will assist in training staff, reviewing analytical data, and maintaining accurate documentation. Strong problem-solving skills, attention to detail, and the ability to work independently are essential.

Work Schedule: Monday - Friday 8am-4:30pm

JOB QUALIFICATIONS:

• BS or MS in Chemistry with a minimum of 5+ years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products and Raw Materials
• Comprehensive knowledge of current Good Manufacturing Practices (cGMP), FDA Guidance, and ICH Guidelines
• Familiar with requirements of various pharmacopeias (USP, EP, JP) and basic regulatory requirements and applies knowledge appropriately to activities
• Strong technical skills in HPLC, and GC required, including theoretical understanding of technique
• Comprehensive knowledge of analytical chemistry, sampling methods and quality control systems
• Experience with computer applications and programs related to laboratory applications (e.g., HPLC, FTIR, UV, LIMS, Lab Calc and GC).
• Quantitative and qualitative techniques and math including statistics
• Spectroscopic techniques and chromatographic systems
• Analyzing problems, identifying alternative solutions and implementing recommendations for resolution of problems
• Researching, analyzing and evaluating new methods, procedures, techniques and equipment, and preparing clean and concise reports and correspondence
• Excellent written and verbal communication skills. Problem solving skills
• Self-starter with a strong work ethic. Must be able to operate with minimal supervision
• Establishing and maintaining cooperative working relations with those contacted in the course of work
• Demonstrated ability to train and/or mentor new employees
• Managing multiple projects, duties and assignments

POSITION RESPONSIBILITIES:

• Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws. Complies with all current Good Laboratory Practices (cGLP), current Good Manufacturing Practices (cGMP), and safety requirements and laboratory Standard Operating Practices (SOPs)
• Perform difficult analytical techniques such as complex procedures involving multiple extractions, titration, timed reactions and normal phase HPLC with minimum assistance and direction
• Responsible for analytical method validation/verification/transfer from R&D to QC
• Create and execute project protocols and reports to support new product method transfers
• Perform testing on raw material, in-process and finished good samples when applicable
• Assist in providing training to new staff and ongoing training to current staff; assist in providing work direction and review, and schedule work in the absence of the manager
• Operate, maintain and troubleshoot all laboratory equipment, solve analytical problems that involve troubleshooting equipment and laboratory method, and report method issues to manager
• Operate general analytical instruments for all routine testing (i.e., HPLC, GC, UV, automatic titrator, and IR).
• Perform wet chemistry tests (i.e., LOD, pH, titration, etc.).
• Label, transcribe and record data on approved report sheets, maintain appropriate documentation (records and lab notebooks) of tests and assays, and perform all necessary calculations associated with test analysis as required by SOPs
• Prepare written reports including investigation, validation studies, and recommendations to revise laboratory test methods and SOPs
• Review and audit analytical data from other laboratory personnel
• Comply with good housekeeping and safety practices; ensure the collection and proper disposal of hazardous waste from laboratory instruments
• Participate in troubleshooting of analytical test methods and laboratory instruments

Perform related duties as assigned

Job Tags

Similar Jobs