Chemist III

Endo•Rochester, MI

About The Position

The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical & 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 guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff. The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical & 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 guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff.

Requirements

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
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
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

Responsibilities

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
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
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
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
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
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