Stability Studies Analyst at Gaia Herbs

Brevard, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jul, 26

Salary

0.0

Posted On

18 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Stability study protocols, HPLC, GC, ICP, UV/Vis spectroscopy, FT-NIR, Multivariate analysis, Principal component analysis, cGMP regulations, LIMS, Technical writing, Experimental design, Regression analysis, ANOVA, Chromatography, Spectroscopy

Industry

Health;Wellness & Fitness

Description

Description JOB SUMMARY: The Stability Studies Analyst is responsible for the management and implementation of the stability studies program at Gaia Herbs. ESSENTIAL DUTIES AND RESPONSIBILITIES: - Authors stability study protocols - Designs and maintains stability studies trackers for sample pull-points and testing progress - Organizes and prepares samples for storage and testing - Ensures that pull-point are performed as scheduled and that testing is completed within the prescribed time frame - Summarizes, tabulates and graphs stability sample data - Authors stability studies reports (final and at-end-of-accelerated-storage conditions) - Performs analytical tests on the stability samples; e.g., organoleptic analyses - Analyzes instrumental data such as HPLC fingerprints and biomarkers - Analyzes spectral data (e.g. UV/Vis or FT-NIR) using multivariate analysis tools such as principal component analysis (PCA) SUPERVISORY RESPONSIBILITIES While this position does not have direct supervision, the Stability Studies Analyst trains, coaches and provides direction to the QC Lab Tech specializing in the Stability Studies and Residue Chemistry programs QUALIFICATIONS: Education and/or Experience: B.S. or M.S. degree in a relevant scientific field (e.g., chemistry, biochemistry, pharmacology, pharmacognosy) or equivalent. Minimum four (4) years of combined post-secondary education and/or industrial laboratory experience operating and maintaining scientific instrumentation on par with the equipment used at Gaia Herbs. Knowledge, Skills and Abilities: Knowledgeable of the requirements of stability studies as described in various guidance documents provided by the FDA and ICH Knowledgeable in the theory of experimental designs Requirements Ability to author technical documents such as stability study protocols, experimental designs and stability study reports Ability to operate laboratory equipment such as HPLC, GC, ICP, UV/Vis, and FT-NIR Knowledgeable in the theory of laboratory techniques such as chromatography, spectroscopy, spectrometry, microbiology and gravimetric analyses Skilled in the use of database software such and laboratory information management software (LIMS) and excel Knowledgeable in cGMP regulations Ability to read and comprehend simple instructions, test methods, standard operating procedures, and memos Ability to write experimental details in a technical manner and to summarize results Ability to effectively present information in one-on-one and small group situations to customers, clients and other employees of the organization Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals Ability to compute rate, ratio and percent and to draw and interpret graphs Ability to perform higher order statistical analysis (such as regression analyses, ANOVA, t-tests, uncertainty determinations, control charts etc.) PHYSICAL DEMANDS Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand and walk, talk or hear. The employee is regularly required to sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel or crouch; and taste or smell. Specific vision abilities required by this job include the ability to be able to view a computer screen. WORK ENVIRONMENT The employee in this position splits time working in an office environment and an analytical laboratory. The employee may infrequently pass through a manufacturing plant, where they would be exposed to moving mechanical parts, airborne particles, toxic or caustic chemicals and loud noise. In the laboratory, the employee may be required to handle common laboratory chemicals such as standards, reagents and solvents. These chemicals may be caustic, flammable, irritating and/or toxic

Responsibilities

The Stability Studies Analyst manages and implements the stability studies program, including authoring protocols and reports. They also perform analytical testing on samples and provide technical guidance to laboratory technicians.