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 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 Compendia 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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.