Research Associate II, Quality Control - Night Shift (2026-037-103)

Gannet BioChem•Huntsville, AL

5d•Onsite

About The Position

The Research Associate II performs Quality Control laboratory activities supporting pharmaceutical CDMO testing, including release, stability, raw material, in-process, and client project needs. The role applies scientific concepts, QC laboratory practices, company procedures, safety practices, cGMP/GLP documentation expectations, and data integrity principles to laboratory work and problem solving. Routine work is performed without instruction, while new assignments receive general instructions. The position prepares samples, standards, reagents, buffers, mobile phases, solutions, and other laboratory materials; performs analytical testing using established methods and instrumentation; and operates, cleans, troubleshoots, and maintains laboratory equipment. The associate also supports the company stability program by coordinating and scheduling testing and reporting and summarizing results in a cGMP capacity. Work includes documenting, reviewing, compiling, and communicating laboratory data and supporting investigations, deviations, atypical results, change controls, CAPAs, technical reports, and client deliverables. The role collaborates with Quality Control, Analytical Development, Process Development, Manufacturing, Quality Assurance, and other teams. It includes maintaining supplies and inventory, keeping the laboratory clean and safe, and complying with safety, environmental, quality, regulatory, and confidentiality requirements. This is an onsite second-shift position working Sunday through Thursday, 4:00 p.m. to 1:00 a.m.

Requirements

Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related scientific field.
At least two years of cGMP/cGLP-related experience.
Knowledge of analytical chemistry, Quality Control laboratory practices, laboratory safety, sample and solution preparation, calculations, laboratory documentation, cGMP expectations, and data integrity.
Hands-on experience with analytical instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, titration, Karl Fischer, dissolution, or wet chemistry techniques.
Ability to solve difficult problems using professional concepts and company policies and procedures, and to analyze data involving identifiable factors.
Ability to work independently on routine assignments and with general instructions on new assignments; execute complex tasks, analyze simple data, identify obvious trends, and train others on simple tasks.
Ability to understand the limits of decision-making authority and seek direction when appropriate.
Ability to document and communicate observations and facts clearly so information can be retrieved and understood.
Ability to manage time across multiple tasks when there are no time or priority conflicts.
Ability to accurately compile, summarize, interpret, and communicate laboratory data, observations, calculations, conclusions, recommendations, and task status in written and verbal formats.
Strong attention to detail, organization, follow-through, and commitment to accurate documentation and data integrity.
Basic math skills, including weights, measures, ratios, dilutions, concentrations, percentages, and unit conversions.
Ability to learn electronic laboratory systems.
Ability to work onsite in a laboratory and pharmaceutical CDMO environment and comply with PPE, safety, quality, and confidentiality requirements.
Must be authorized to work in the United States.
Must be able to pass pre-employment drug screening and background check for employment consideration.
Must be able to lift 25 pounds and sit or stand for long periods.
Must be able to wear respiratory protection for certain essential tasks.
Must be able to access elevated work surfaces using vertical ladders or stairs.
Must be able to accurately detect color and have 20/20 vision, with or without corrective lenses.

Nice To Haves

Experience in Quality Control, analytical testing, pharmaceutical development, CDMO operations, analytical development, or another regulated laboratory environment.
Working knowledge of Microsoft Office/365 tools, including Word, Excel, Outlook, and Teams.

Responsibilities

Perform Quality Control laboratory activities supporting pharmaceutical CDMO testing, release, stability, raw material, in-process, and client project needs.
Prepare and support preparation of samples, standards, reagents, buffers, mobile phases, solutions, and laboratory materials according to approved procedures and project instructions.
Support the stability program by coordinating and scheduling testing and reporting and summarizing results in a cGMP capacity.
Perform assigned analytical testing and laboratory support using established practices, procedures, and analytical techniques.
Operate, clean, troubleshoot, maintain, and support readiness of laboratory equipment and analytical instrumentation.
Analyze simple data, identify obvious trends, review chromatograms, calculations, observations, and results, and appropriately escalate unexpected results or technical issues.
Accurately document laboratory work, observations, calculations, instrument use, sample preparation, test results, deviations, and other required information in approved records and systems.
Compile, summarize, and communicate analytical data, observations, conclusions, task status, and supporting information to reviewers and relevant teams.
Follow approved test methods, specifications, SOPs, protocols, safety procedures, and laboratory controls, and seek direction when appropriate.
Support investigations, deviations, out-of-specification or atypical result evaluations, change controls, CAPAs, troubleshooting, technical reports, and client deliverables by gathering and organizing relevant information.
Draft, review, or revise laboratory documentation, including methods, protocols, worksheets, reports, SOPs, and forms, as assigned.
Train others on simple laboratory tasks, procedures, documentation practices, equipment use, or workflow expectations, as assigned.
Work with internal teams to support timely completion of assigned tasks.
Maintain laboratory supplies, standards, reagents, samples, retain and reference materials, and inventory records.
Maintain a clean, safe, and organized laboratory work area and comply with applicable safety, environmental, quality, regulatory, and confidentiality requirements.
Perform other duties as assigned.