THE COMPANY:
Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.
Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.
PRIMARY PURPOSE:
The Quality Control Laboratory Chemist II will ensure the timely and accurate testing of raw materials, in-process, and finished products by applying validated analytical methods and sound scientific principles, while maintaining compliance with regulatory and quality standards. Contribute to laboratory efficiency, data integrity, and continuous improvement initiatives, and support the development of team capabilities through training and technical guidance.
MAJOR DUTIES AND RESPONSIBILITIES:
- Testing of incoming materials, in process/bulk/intermediate, finished product, and stability samples using wet bench and physical techniques, plus instrumentation such as FTIR, UV-VIS, etc., and basic chromatography while growing and training in complex chromatographic analyses
- Accurately records raw data and analyzes, calculates, and interprets the results
- Enters results in appropriate lab systems, such as ERP and LIMS
- Performs daily verification activities, basic calibration and preventative maintenance tasks, and assists with calibration of HPLC, GC, AA, TOC as part of ongoing training
- Is qualified to review and disposition samples/lots in their respective area
- Ability to train and qualify junior co-workers
- Assists in out of specification (OOS) test results and investigation
- Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and other approved test methods
- Participates in method verification/validation/transfer tasks as directed by supervisor and may provide review of raw data and/or reports
- Maintain reagents in laboratory including but not limited to inventory, current MSDS, PPE required for handling, waste generation and disposal
- May flex to other Quality teams/departments to assist when needed
- Promote GMP and safety throughout the facility
- Promote continuous improvement and customer satisfaction
- Assists to 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 Quality Supervisor
QUALIFICATIONS:
Required
- Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.
- Knowledge of chemical safety and protective equipment.
- Knowledge of various analytical equipment and techniques utilized in an analytical laboratory.
- Ability to follow established priorities, work independently and productively.
- 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.
