Chemist

Staff Management Group•Chestnut Ridge, NY

11d•Onsite

About The Position

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.

Requirements

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
Demonstrated proficiency with various laboratory techniques/instruments: HPLC, UVVis, 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
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
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

Nice To Haves

Master’s Degree in above disciplines with 1+ years’ relevant analytical lab experience preferred

Responsibilities

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