Full Time (M-F)
Salary Commensurate with ExperienceDuties:
Qualifications & Requirements:
- Develop and conduct analysis in compliance with cGMP requirements, compendia standards, and internal procedures
- Maintain accurate record of analysis to company standards
- Prepare test solutions, volumetric solutions, and samples used in analysis
- Perform assigned sampling, physical, chemical tests and assay of ingredients, in-process, and finished products
- Competently use a variety of analytical instruments such as HPLC (Shimadzu), GC (Varian), and FTIR (Thermo).
- Perform maintenance and calibrations of laboratory instruments /equipment
- Oversee 3rd party laboratory submissions and result review.
- Comply with all regulatory and company requirements : safety, housekeeping, laboratory chemical waste, cGMP, cGLP, & documentation
- Create and/or reviewing test methods and standard operating procedures
- Immediately communicate any nonconforming data or unexpected occurrences and perform OOS investigations
- Organize work schedule to complete assigned tasks efficiently and on schedule
5-7 years of experience in an analytical laboratory in a regulated faced paced FDA environment
Working knowledge of cGLP and Dietary Supplement FDA/GMP regulations,
Experience in OOS investigation and documentation
Shimadzu HPLC experience is preferable.
Authorization to work in the US indefinitely w/o restriction or sponsorship
Ability to work independently as well as in a team environment
Good communication skills and ability to collaborate easily with others
Accurate detailed record keeping skills
Willingness and ability to learn new techniques
Ability to effectively organize work flow to accommodate needs of production
Knowledge of lab safety and hazardous materials management
Adaptable work style that can accommodate and support changing business needs.