Chemist II

About the role

The Chemist II position is responsible for performing physical and chemical tests on raw materials and finished products in compliance with Current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) requirements, FDA regulations, and Pharmaceutical Specialties, Inc. (PSI) Standard Operating and Analytical Procedures.

Responsibilities

• Perform physical and chemical tests on raw materials and finished products, including:
  • Infrared Spectroscopy
  • UV-Vis Spectroscopy
  • pH
  • Titrations
  • Quantitation
  • HPLC
  • GC
  • Viscosity (Rheology)
  • Specific Gravity
  • TOC
  • Wet chemistry
  • ICP-OES
• Follow Standard Operating Procedures (SOP).
• Document work clearly and accurately.
• Ensure the accuracy and validity of test results.
• Adhere to hygiene and safety rules in the Quality Control laboratory and other departments.
• Maintain a clean lab and assist 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.
• Author and edit SOPs.
• Demonstrate proficiency in pipetting and weighing.
• Safely handle chemicals, including strong acids and bases.
• Execute stability protocols, including testing.
• Perform related duties as assigned.

Requirements

• 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
• Analytical laboratory experience required.
• cGMP experience required.
• Experience with Quality Control testing preferred.
• Experience with advanced analytical techniques required.
• Experience with analytical method validation activities required.
• Proficiency in MS Word and Excel required.
• Proficiency in other laboratory computer systems, such as OpenLab, preferred.
• Experience with document management and equipment management systems preferred.
• Experience in statistical analysis preferred.
• Must be authorized to work for ANY employer in the U.S.

Skills

• Ability to use judgment in decision-making that impacts safety, quality, regulatory compliance, and brand value.
• Self-motivated with the ability to work independently and exercise good judgment.
• Strong communication skills and ability to work with multiple departments.
• Ability to multi-task between routine testing and other projects.
• Experience revising and authoring technical documents required.
• Good written and verbal communication skills for interdepartmental projects.
• Ability to read, interpret, and follow documents such as directions, instructions, safety rules, and procedure manuals in English.
• Ability to record written information accurately.
• Ability to apply common sense and understanding to carry out instructions furnished in written, verbal, diagram, or schedule form.

Work Environment

• Occasionally exposed to fumes, airborne particles, and moving mechanical parts.
• Moderate noise level in the work environment.

Physical Demands

• May be required to sit, stand, walk, use hands and arms, and talk or hear.
• Must occasionally lift and/or move up to 50 pounds.
• Requires good close vision and ability to see color at close and far distances.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Schedule

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

Travel

This position may require travel for educational purposes.

Benefits

• Health Insurance (greatly subsidized by the company)
• Dental, Life, and Disability Insurance at no cost to employees
• HSA, HRA, and Day Care Assistance Plans
• 401(k) Retirement Plans with Profit-Sharing
• Bonus opportunities
• Generous PTO and paid holidays

Pay

The starting salary for this position is $70,000 per year.