Chemist II

The Chemist II position responsibilities include both physical and chemical tests on raw materials and finished products according to Current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) requirements, the Food and Drug Administration (FDA) and Pharmaceutical Specialties, Inc. Standard Operating and Analytical Procedures.

• Perform physical and chemical tests on raw materials and finished products:
  • Infrared Spectroscopy
  • UV-Vis Spectroscopy
  • pH
  • Titrations
  • Quantitation
  • HPLC
  • GC
  • Viscosity (Rheology)
  • Specific Gravity
  • TOC
  • Wet chemistry
  • ICP-OES
• Be able to follow Standard Operating Procedures (SOP).
• Document work in a clear and organized manner.
• Be accountable for the accuracy and validity of test results.
• Follow hygiene and safety rules for the Quality Control laboratory and other departments.
• Maintain a clean lab and assists in purchasing.
• Understand and perform IQ/OQ/PQ and calibration of equipment.
• Develop and validate analytical methods (ICH/USP compliant)
• Assist with new methodology for raw materials and finished products.
• Author and execute method validation protocols and reports.
• Be able to assist with new methodology for raw materials and finished products.
• Author and edit SOP’s.
• Pipetting skills are required.
• Weighing skills are required.
• Must be able to handle chemicals, including strong acids and bases, safely.
• Execute stability protocols including testing.
• Performs related duties as assigned.

• Experience in the area of Pharmaceutical/Cosmetic Chemistry preferred.
• Analytical laboratory experience is required.
• cGMP experience is required.
• Experience with Quality Control testing is preferred.
• Experience with advanced analytical techniques is required.
• Experience with analytical method validation activities is required.
• Able to use judgement to make decisions in carrying out assignments that have impact on safety, quality, regulatory compliance and brand value for PSI and its clients.
• Be self‑motivated with ability to work independently with a strong sense of good judgement.
• Good communication skills and the ability to work with multiple departments.
• Able to multi‑task between routine testing and other projects.
• Experience revising and authoring technical documents is required.
• Proficiency in MS Word and Excel required.
• Proficiency in other laboratory computer systems, such as Open Lab, is preferred.
• Experience with other computer systems, such as document management and equipment management is preferred.
• Experience in statistical analysis preferred.

• There are no supervisory responsibilities for this position.

• While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and moving mechanical parts. The noise level in the work environment is usually moderate.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.

• While performing the duties of this job, the employee may be required to sit and use hands. The employee will also be required to stand, walk, use hands and arms, talk and hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision requirements are good close vision and to be able to see color at close and far distances.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Monday – Friday, 7:30 a.m. to 4:30 p.m.
• Capability to work extended hours if necessary.

• This position may be required to travel for educational purposes.

• Bachelor’s degree in chemistry or related science with 2-5 years of GMP Pharmaceutical/OTC experience.
• Master’s degree in chemistry preferred.
• Demonstrated experience with:
  • Method Validation
  • Stability indicating methods
  • Data integrity compliance
  • Instrument Qualification
• Strong knowledge of chromatography techniques
• Experience writing technical reports

• Must be able to work with Quality Assurance (QA) department, Research and Development (R&D) department, Production department and Regulatory Department.
• Good…