CHEMIST III

Formulated Solutions Innovates, Formulates and Creates consumer brands. We put together a broadly talented team of experts in manufacturing, production, laboratory, regulatory, distribution and marketing, that possesses an unparalleled drive to deliver market-ready products of the highest quality. Our in-house technologies in Aerosol, Biochemistry, Cosmetic, Pharmaceutical and Polymer Chemistry, coupled with innovative package design and strategic marketing services, provides clients with one of the fastest design-to-market solutions in the world. We serve companies in pharmaceutical, cosmetic, personal care and specialty chemical applications. We also support small and large companies in generating and producing unique products for the retail market.

Formulated Solutions offers a wide range of benefit options for our full-time employees, allowing them to find the right plan to enroll into. We also offer 401k with a company match and much more! If you are hard-working, self-motivated and looking for a new and exciting career opportunity, apply today!

PRIMARY PURPOSE:

Ensure continuity in laboratory abilities in HPLC, Gas Chromatography and AA. Must have extensive cGMP experience and be able to provide leadership and mentoring to Chemist I and Chemist II. Must have thorough understanding of Good Laboratory Practices, Good Documentation Practices and Method Validation. Must have experience in Method Validation including developing methods, preparing protocols and writing summary reports. Must have experience in writing Standard Operating Procedures.

MAJOR DUTIES AND RESPONSIBILITIES:

• Perform all of the activities for qualifying, validating, and maintaining laboratory equipment.
• Perform all of the activities for transferring and validating analytical methods.
• Revise and write Test Methods and SOP’s.
• Testing of incoming materials, in process samples and finished product testing.
• Accurately records raw data and analyzes, as well as calculates and interprets the results.
• Responsible for out of specification test results, investigation and implementation of corrective actions.
• Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and other approved test methods
• Maintain analytical reagents in laboratory including but not limited to: inventory, current MSDS, PPE required for handling, waste generation and disposal.
• Assist Validation teams in cleaning validation activities.
• Promote GMP and safety throughout the facility.
• Promote continuous improvement and customer satisfaction.
• Follow-up on OOS’s and CAPAs to verify compliance
• Potential exists for exposure to potentially harmful chemicals.
• Participate in other activities as assigned by the Lab Manager or VP Quality.

QUALIFICATIONS:

Required

• Knowledge of Compendium testing.
• Working knowledge of FDA regulation for drug/device especially for the lab.
• Ability to use a personal computer and peripheral equipment to accurately enter an analyze data and produce reports.
• Knowledge of chemical safety and protective equipment.
• Knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectrum, HPLC, GC, atomic absorption.
• Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.
• Ability to handle and resolve recurring problems.
• Communicate with others clearly and concisely.
• Ability to work in a dynamic fast paced environment-sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
• Must be able to lift up to 15 pounds.

EDUCATION AND TRAINING:

• Bachelor’s degree in Chemistry or appropriate discipline.
• Must have four to five years experience working in an analytical laboratory in an FDA regulated industry.

ENVIRONMENTAL DEMANDS

• Normal office environment
• Exposure to chemicals and/or other potential hazards