Job Summary - a concise overview of the job
The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Typically supports one Par business, at a single site
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Analysis & Testing
- Conducts laboratory analyses: 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
- May review and approve laboratory test data and documentation for completeness and compliance
- Is alert to and detects abnormalities during performances of tests and reviews
- May perform 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
- Learns to troubleshoot instrument/chromatography problems
- With guidance, participates in OOS/OOT/NOE and other investigations
- Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
- May draft, edit and review 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
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Bachelor of Science Degree in chemistry, chemical engineering or related field with 2+ years’ relevant analytical laboratory experience OR
- Master’s Degree in above disciplines with 1+ years’ relevant analytical lab experience preferred
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Demonstrated 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.
- Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS
- Has demonstrated competence in conducting chemical analyses
- Good knowledge of wet chemistry techniques
- In-depth working knowledge of laboratory software and chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax)
- Competency in Microsoft Office Suite
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Ability to display and analyze data in a logical manner
- Good verbal and written communication skills as well as good computer skills
- Attention to details and accurate record keeping
- Establish and maintain cooperative working relationships with others
- Solid organizational skills
- Ability to train less senior staff and develop laboratory skills and ability
- Ability to take initiative, set priorities and follow through on assignments
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
- Must occasionally lift and/or move up to 15-25 lbs.
- Ability to wear personal protective equipment, including respirators, gloves, etc.
- Specific visions abilities are required by this job include close vision and color vision
- Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods