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. Must have thorough understanding of Good Laboratory Practices and Good Documentation Practices. Must have experience in writing Standard Operating Procedures.
MAJOR DUTIES AND RESPONSIBILITIES:
- 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.
· 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 two or more years experience working in an analytical laboratory in an FDA regulated industry.
Formulated Solutions, LLC is a complete manufacturing and product development company - offering clients nearly all aspects of brand creation and product fulfillment. Our main focus is on consumer healthcare, cosmetic, aerosol and drug development. Over 250 products on the shelf today were developed or modified by our industry-recognized team members. Our dedicated people make success happen. At Formulated Solutions, we pride ourselves in our teamwork, innovation and customer-focused processes. We have the advantage of an informal small-company culture with big-company ideas and a global reach. Our innovative products are sold world-wide. We effectively blend state-of-the-art e-commerce with personal contact to provide unmatched products and customer support thanks to our outstanding team.