Senior Chemist

Eagle Labs, Inc•Seminole, FL

About The Position

GENERAL PURPOSE Provide QC support for general testing and administrative support for raw materials and finished products. 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.

Requirements

Education: Bachelor’s degree in Chemistry, Microbiology, or related scientific discipline from an accredited 4- year college/university
Experience: 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.

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.
Write and execute validation protocols and reports per current industry standards.
Write methods and evaluating methods for validation potential.
Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
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.