Chemist I, Quality Control

Job Summary

The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.

Accountability

Responsibilities

Analysis & Testing

• Conducts routine 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

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 disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
• Under close supervision, learns to troubleshoot basic instrument problems

Investigations

• With guidance, participates in OOS/OOT/NOE and other investigations
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor
• May assist in drafting, editing, and reviewing SOPs and laboratory investigations

Training

• Maintains assigned training records current and in-compliance
• May assist in the training of less senior laboratory staff

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

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 analytical chemistry coursework required.
• Some pharmaceutical laboratory experience preferred.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• 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.
• Basic knowledge of wet chemistry techniques
• Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS
• Competency in Microsoft Office Suite

Skills

&

Abilities

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 take initiative, set priorities and follow through on assignments

Physical Requirements

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