Analyst II, Laboratory

SFI Health

4d•$28 - $32•Onsite

About The Position

Essential job functions: Coordinate and manage testing of raw materials and finished products with qualified third-party laboratories. Perform in-house physical testing per specifications, including FTIR, loss on drying (LOD), bulk density, particle size, disintegration, water activity, and related analyses. Review and interpret analytical data to assess compliance with specifications and support release of raw materials and finished products for production and distribution. Conduct and document out-of-specification (OOS) and atypical result investigations for materials and environmental monitoring, including root cause analysis and supporting data. Ensure laboratory records, data, and reports comply with internal procedures, cGMP requirements, and applicable regulatory standards (e.g., 21 CFR Part 111). Review and maintain raw material and finished product specifications; manage specification updates to ensure alignment with formulations, label claims, and testing capabilities. Support raw material qualification activities, including review of supplier documentation, test methods, and Certificates of Analysis (COAs) in collaboration with Supply Chain and Product Development. Evaluate analytical methods for suitability and alignment with intended use, particularly for bioactive compounds and botanical materials. Communicate and collaborate with third-party laboratories regarding test methods, investigations, and atypical results. Partner cross-functionally with Quality Assurance, Production, Product Development, Supply Chain, and Customer Service to resolve quality and testing-related issues. Prepare, review, and approve Certificates of Analysis/Compliance and related documentation. Maintain and manage raw material and finished product retention samples in accordance with the established retention schedule. Author analytical summaries, investigation reports, and supporting documentation as required. Support customer complaint investigations through testing, product identification, and retention sample comparisons; provide analytical data and findings to QA for final documentation and response. Secondary job duties: Review and prepare specifications for raw materials and finished products to ensure accuracy, completeness, and data integrity. Maintain a clean, organized, and inspection-ready laboratory environment. Support continuous improvement initiatives

Requirements

Bachelor’s degree in Analytical Chemistry, Biochemistry, Pharmacy, or a related scientific field preferred.
Minimum of 2 years of experience in an analytical, pharmaceutical, nutraceutical, or biotechnology laboratory. Equivalent combinations of education and experience will be considered.
Strong analytical thinking and problem-solving skills
Solid understanding of cGMP principles and laboratory compliance requirements
Ability to manage multiple priorities and meet time-sensitive deadlines
Strong attention to detail with a focus on data integrity
Effective cross-functional communication skills
Ability to work independently and exercise sound judgment
Proficiency in Microsoft Office (Word, Excel, Outlook)

Nice To Haves

Experience with ERP systems such as SAP preferred.

Responsibilities

Coordinate and manage testing of raw materials and finished products with qualified third-party laboratories.
Perform in-house physical testing per specifications, including FTIR, loss on drying (LOD), bulk density, particle size, disintegration, water activity, and related analyses.
Review and interpret analytical data to assess compliance with specifications and support release of raw materials and finished products for production and distribution.
Conduct and document out-of-specification (OOS) and atypical result investigations for materials and environmental monitoring, including root cause analysis and supporting data.
Ensure laboratory records, data, and reports comply with internal procedures, cGMP requirements, and applicable regulatory standards (e.g., 21 CFR Part 111).
Review and maintain raw material and finished product specifications; manage specification updates to ensure alignment with formulations, label claims, and testing capabilities.
Support raw material qualification activities, including review of supplier documentation, test methods, and Certificates of Analysis (COAs) in collaboration with Supply Chain and Product Development.
Evaluate analytical methods for suitability and alignment with intended use, particularly for bioactive compounds and botanical materials.
Communicate and collaborate with third-party laboratories regarding test methods, investigations, and atypical results.
Partner cross-functionally with Quality Assurance, Production, Product Development, Supply Chain, and Customer Service to resolve quality and testing-related issues.
Prepare, review, and approve Certificates of Analysis/Compliance and related documentation.
Maintain and manage raw material and finished product retention samples in accordance with the established retention schedule.
Author analytical summaries, investigation reports, and supporting documentation as required.
Support customer complaint investigations through testing, product identification, and retention sample comparisons; provide analytical data and findings to QA for final documentation and response.
Review and prepare specifications for raw materials and finished products to ensure accuracy, completeness, and data integrity.
Maintain a clean, organized, and inspection-ready laboratory environment.
Support continuous improvement initiatives