AR&d Chemist II

PRIMARY PURPOSE: Develop, transfer and validation of HPLC, Gas Chromatography, ICP and AA methodology.

Must have extensive cGMP experience and be able to provide leadership and mentoring to Chemist I and Chemist II in QC Laboratory.

Must have thorough understanding of Good Laboratory Practices and Good Documentation Practices, as well as compendial methodology.

Must have experience in writing Standard Operating Procedures, Protocols and Reports.

MAJOR DUTIES AND RESPONSIBILITIES: Perform all the activities for development, transfer and validation of analytical methods.

Revise and write Validation Protocols, Test Methods, Validation Reports and SOP's.

Verification of testing of incoming materials, using compendial test methods (USP, PhEUR, JP) Testing of premarket stability samples, in process samples and finished product testing, using a variety of techniques, such as HPLC, GC, AA, ICP, UV/Vis, etc.

Accurately records raw data and analyzes, as well as calculates and interprets the results.

Occasional customer interaction in a professional environment.

Responsible for out of specification test results, investigation, and implementation of corrective actions.

Ensure testing is performed accurately and in compliance with GLP, cGMP, cUSP, SOP and other approved test methods and protocols.

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.

Support laboratory troubleshooting needs by interacting with vendors, customers and other relevant SMEs.

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 CSO.

QUALIFICATIONS: Required * Knowledge of Compendia testing.

* Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo.

This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.

* Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of goods.

* Working knowledge of FDA regulations for laboratory testing and disposition.

* 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.

* Expertise in various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectroscopy, HPLC, GC, ICP, UV/VIS, atomic absorption.

* Ability to establish priorities, work independently, productively, and proceed with objectives without supervision.

* Ability to handle and resolve recurring problems.

Understanding the implications of new information for both current and future problem-solving and decision-making.

* Ability to troubleshoot HPLC, GC, ICP and AA analyses * Ability to communicate effectively, concisely in a professional manner with clients and others.

* 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 related discipline.

* Must have three or more years' experience working in an analytical laboratory in an FDA regulated industry.