Salary Range: Salary depending on experience
Location: Laurelton, NY (On-Site)
This is a fulltime, on-site exempt salaried position. SALARY RANGE IS BASED ON EXPERIENCE LEVEL!
Previous Generic Pharma or Pharma experience a plus!
As a Gas Chromatographer, your role will be to use analytical techniques to separate and analyze samples that can be vaporized without thermal decomposition and to support the Gas Chromatography testing for drug substances and drug products.
Essential Job Function include (but are not limited to):
Perform higher level lab testing of raw materials, specifically GAS CHROMATOGRAPHY as per approved test methods, in compliance with all QC & company SOPs and cGMPs.
Should work independently and run a variety of GC Instruments with Head Space and direct injection.
The analyst should be able to develop GC methods independently
Conduct method validation testing and documentation activities. process and cleaning validation testing and documentation & documentation activities.
Conduct method verification/validation/optimization/transfer activities as needed.
Assist Lab management with conducting lab investigations & deviations,
Assists Laboratory Management with conducting, preparing for and responding to laboratory audits and agency inspections.
Performs laboratory auditing as required.
Maintain neat, orderly & cGMP-compliant documentation for all testing performed including lab notebooks, chromatograms & report forms, C of A’s/spec sheets & glassware labeling.
Provide training and mentorship to level 1 and 2 chemists.
Adhere to and promote all lab health, safety, and good housekeeping practices. Assume leadership role in lab clean-ups and related initiatives.
Provides analyst training, development, and mentorship to level 1 and level 2 chemists; leads by example
Handle and document all aspects of controlled substances responsibly & in full adherence to federal and company regulations and policies.
Complete projects accurately and timely with minimal errors, repeats, and analyst-induced investigations/deviations. Follows Management’s instructions to meet deadlines and priorities
Participate and contribute to lab and company meetings and training sessions.
Requirements:
Minimum Bachelor of Science degree in Chemistry or a related scientific field.
At least 4 - 5 years of laboratory experience is preferred, ideally in a pharmaceutical environment with solid dosage forms.
Advanced verbal and written communication skills, including technical writing skills to draft reports and the ability to read and comprehend technical documents, instructions, diagrams, and schedules.
Excellent interpersonal skills to interact with all colleagues and supervisors.
Excellent analytical testing skills in a cGMP laboratory environment.
Excellent time management and detail orientation skills to complete projects accurately with minimal errors.
Excellent verbal and written command of English language.
Ability to perform and produce quality work in a Pharma environment that is highly regulated by governmental agencies such as FDA and DEA.
Demonstrated proficiency with high-level laboratory instrumentation and operating software.
Must be able to work well under pressure to follow specific instructions and set priorities in a deadline-driven environment.
Ability to work with chemicals, reagents, and solvents in the laboratory, which includes a combination of physical activity.