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GENERAL PURPOSE
- Provide QC support for general testing and administrative support for raw materials and finished products.Â
- Follow pertinent SOPs to ensure cGMP compliance.
POSITION RESPONSIBILITIES
- Independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines.
- Able to write and execute validation protocols and reports per current industry standards. Experience with writing methods and evaluating methods for validation potential. Extensive knowledge of USP and ICH guidelines.
- Must have familiarity with HPLC, GC, NIR, water activity, UV-Vis, ICP-MS/AA and other pertinent instrumentation.
- Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.
- Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
MINIMUM QUALIFICATIONS
Education: Bachelor’s degree in Chemistry, Microbiology, or related scientific discipline from an accredited 4- year college/university
Experience:Â 5 years of experience in Quality Control in the pharmaceutical, dietary supplement or cosmetic industry.
Knowledge, Skills, and Abilities: Strong working knowledge of cGMP, FDA, USP, ICH, and related quality guidelines. Proficiency with laboratory instrumentation (HPLC, GC, UV-Vis, ICP-MS, etc.). Excellent organizational skills, attention to detail, and ability to manage multiple priorities. Strong communication and leadership skills with ability to resolve conflicts and guide staff effectively.
Benefits
- Medical Insurance
- Vision Insurance
- Dental Insurance
- Paid Time Off
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