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Gannet BioChem · 5 hours ago

Sr. Research Associate, Quality Control - Night Shift (2026-008-103)

Huntsville, AL

Full-time

Onsite

Senior Level

5+ years exp

Gannet BioChem is seeking a Sr. Research Associate for their Quality Control team. The role involves conducting complex analyses and ensuring compliance with quality standards, while also providing training and support to junior analysts.

BiopharmaChemicalManufacturing

Responsibilities

This is a 2nd Shift role. Regular work hours are 4:00pm – 1:00am, Sunday through Thursday

Works on complex problems in which analysis of data requires evaluation of various factors

Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

Responsible for conducting routine and non-routine analysis of In-Process/Reaction intermediate and Finished materials according to standard operating procedures

Compiles data for documentation of test procedures and prepares reports

Calibrates and maintains lab equipment

May develop testing methods

Reviews data obtained for compliance to specifications and reports abnormalities

Revises and updates standard operating procedures as needed

May perform special projects on analytical and instrument problem solving

Applies knowledge of good manufacturing practices and good laboratory practices daily basis

Works on complex problems where analysis of situations or data requires an evaluation of intangible variables

Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results

Acts independently to determine methods and procedures on new assignments

Provides data analysis, troubleshooting and problem solving

Provides training to junior analysts. Supports QC release and stability testing

Performs various analyses, such as NMR, HPLC, UV-Vis spectroscopy, GC, particle size determination and moisture analysis

Maintains accurate and well-organized laboratory records and worksheets

Assists with other projects as assigned

Recognize OOT/OOS results and appropriately conduct investigation

May perform rotational on-call duties for monitoring of storage chambers, as necessary

Qualification

CGMP analytical experienceHPLCGCNMRData analysisTroubleshootingFDA regulationsEmpower softwareProblem-solvingComputer skillsIndependenceOrganizationOral communicationWritten communicationTeamwork

Required

A minimum of a Bachelors degree in a scientific discipline with a minimum of 5 years cGMP analytical experience is required

Must have a demonstrated working knowledge of scientific principles

Practical experience in analytical chemistry and general laboratory wet chemistry techniques required

Experience in HPLC a must, with GC/ NMR experience, being a plus

Experience in data analysis, troubleshooting and problem-solving skills is a must

Knowledge of FDA regulations and cGMP experience required

Good oral and written communication skills are required

Good computer and documentation skills are required

Experience with Empower software is required

Must be well organized and willing to work as part of a team

Must be able to work independently and flexible

Must be able to pass pre-employment drug screening and background check for employment consideration

Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function

Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices

Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents

Employees must be able to maneuver themselves under 30 inch clearances

Employees must be able to accurately detect color and have 20/20 vision (with/without corrective lenses)