QC Analyst II

Buffalo, NY

Safetec of America, Inc. is your trusted source for infection control, first aid and compliance products for over 29 years. We are a fast-growing OTC pharmaceutical company located in Buffalo, NY. We are a family owned, local business with a reputation of retaining employees because we treat them like family. 

Come work for a company that is diverse, a WNY Best Place to Work, and is recognized for excellence in manufacturing!

If you have the ambition and drive to take on new challenges apply today!

Monday - Friday 10am - 6:30pm

Responsibilities:

Performance of diversified chemical testing as needed by current USP, Standard Operating Procedures (SOPs), Test Methods (TM), Good Laboratory Practices (GLPs), and Good Manufacturing Practices (GMPs) on raw materials, bulk liquids, and finished products. The testing may include but not limited to: pH determination, viscosity, specific gravity, etc. Conduct wet chemical titration to determine the percentage of activity on various solutions and raw materials, bulk liquids, and finished products and by the use of instruments such as: GC, HPLC, IR, UV, Auto-titrator, etc.

  Determine the percentage of various components as required by specifications

  • Perform identification of various chemicals or formulations as per methodology USP/NF and other test requirements
  • Ensure that all results are neatly and accurately recorded in appropriate laboratory logs or other designated forms.
  • Provide support for purchasing analytical supplies
  • Prepare solutions and titrants when required
  • Clean laboratory work related area
  • Prepare and maintain laboratory test solutions
  • Coordinate release of liquid batches including designation of reassay/expiration date.
  • Assist in the sampling, testing and release of raw materials when needed.
  • Handles special projects and assignments as delegated (method transfer, method validation).
  • Train lower level Chemists in the use of instruments, methodology, SOPs, TMs, GLP, GMPs, etc.
  • Test raw materials, batches, and finished products in a timely manner.
  • Ensure release of raw materials, batches, and finished products are done efficiently.
  • Perform review of laboratory notebooks for accuracy and completeness.
  • Adequate understanding of the requirements of the USP and GMP requirements as applied to the testing of pharmaceuticals.
  • Set up and operate complex laboratory equipment such as HPLC and GC inclusive of any computerized software required for the operation of the equipment or analysis of results. Makes recommendations with respect to the cause and resolution of equipment issues or malfunctions.
  • Perform chemical testing as needed using TMs, SOPs, and as per methodology USP/NF and other test requirements on raw materials, bulk liquids, and finished products. The testing may include but is not limited to: HPLC/GC, IR, UV, wet chemistry Auto-titrator, etc.) for raw materials, bulk liquids, and finished products.

 

EDUCATION/CERTIFICATION:

  • Bachelor's degree in Chemistry, Analytical Chemistry, other related science

 EXPERIENCE REQUIRED:

  • A minimum of 3 – 6 years’ experience testing pharmaceutical products in a GMP regulated QC laboratory is desirable. Experience in chemical analysis of other materials may be considered if applicable.

 SKILLS/ABILITIES:

  • Must have good communication skills.
  • Demonstrate ability to perform work accurately and be able to follow test methodology.
  • Ability to perform well under pressure and work with minimum supervision.
  • Able to delegate the required testing to competent and trained chemists.
  • Demonstrate ability to perform work accurately and be able to follow test methodology.
  • Ability to read and comprehend methods and other instructional documents such as SOPs
  • Knowledge of Analytical techniques and able to incorporate them into daily tasks.
  • Computer literate.
  • Demonstrate ability to perform work accurately and be able to follow test methodology.
  • Ability to perform well under pressure and work with minimum supervision.  
  • Good interpersonal skills that support working in a team environment.