Chemist II, Quality Control

JOB SUMMARY

The Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.


All incumbents are responsible for following applicable Division & Company policies and procedures.

KEY ACCOUNTABILITIES

Analysis & Testing

• Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Uses laboratory software for analyses
• Reviews and approves laboratory test data and documentation for completeness and compliance
• Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor
• Performs lab methods transfer and participate in method validation/verification studies

Lab Equipment

• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
• Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
• Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs

Investigations

• Detects, conducts and reports on OOS/OOT/NOE and other investigations
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
• Writes, edits and reviews SOPs and laboratory investigations

Training

• Maintains assigned training records current and in-compliance
• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures

Compliance

• Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting
• Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Follows internal processes related to controlled substances

Safety

• Follows EH&S procedures to ensure a safe work environment
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

QUALIFICATIONS

Education & Experience

• Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years' relevant analytical laboratory experience OR
• Master's Degree in above disciplines with 2+ years' relevant analytical lab experience

Knowledge

• Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
• Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
• Has demonstrated competence in conducting chemical analyses
• Strong knowledge of wet chemistry techniques
• Competency in Microsoft Office Suite

Skills & Abilities

• Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management
• Ability to display and analyze data in a logical manner
• Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information
• Ability to display and analyze data in a logical manner
• Strong verbal and written communication skills as well as good computer skills
• Strong attention to details and accurate record keeping
• Establish and maintain cooperative working relationships with others
• Solid organizational skills
• Ability to coach less senior staff and develop laboratory skills and ability
• Ability to take initiative, set priorities and follow through on assignments