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

Gannet BioChem; Huntsville (AL); Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

Gannet BioChem is seeking a Quality Control laboratory professional for a second shift (4:00 pm–1:00 am, Sun–Thu) to support pharmaceutical CDMO testing and release. You will apply QC practices, data integrity, and cGMP/GLP standards to solve problems in a practical way.

You will prepare samples and run analytical tests (HPLC/UPLC, GC, UV-Vis, FTIR, titration, Karl Fischer, dissolution, wet chemistry), document results, and train other staff as needed.

Qualifications

• Bachelor's degree required in chemistry or a related field.
• Minimum two years of cGMP/cGLP experience.
• Experience in Quality Control, analytical testing, CDMO operations, or a regulated lab.
• Hands-on with analytical instrumentation (HPLC/UPLC, GC, UV-Vis, FTIR, titration, Karl Fischer, dissolution, wet chemistry).
• Ability to document data and maintain accurate records per SOPs.

Responsabilités

• Perform QC lab activities to support testing and client projects.
• Prepare samples, standards, reagents, buffers, and mobile phases per procedures.
• Execute analytical testing using validated methods (HPLC/UPLC, GC, UV-Vis, FTIR, etc.).
• Document observations, calculations, and results with accuracy.
• Train others on simple tasks and assist in method transfer.
• Collaborate with QA, Analytical Development, and manufacturing teams.

Connaissances

Quality Control

Analytical Testing

cGMP/GLP

Data Integrity

Laboratory Documentation

HPLC/UPLC

GC

UV-Vis

FTIR

Titration

Karl Fischer

Dissolution

Wet Chemistry

SOP Adherence

Team Collaboration

Formation

Bachelor's degree in Chemistry/related Scientific Field

Outils

HPLC/UPLC

GC

UV-Vis

FTIR

Titration

Karl Fischer

Dissolution

Wet Chemistry

Description du poste

• This is a second shift role that operates between 4:00 pm to 1:00 am, Sunday through Thursday
• With no instruction on routine work and general instructions on new assignments, perform Quality Control laboratory activities to support pharmaceutical CDMO testing, release, stability, raw material, in-process, and client project needs.
• Apply professional scientific concepts, Quality Control laboratory practices, company policies, procedures, safety practices, cGMP/GLP documentation expectations, and data integrity principles to solve a wide range of difficult problems in imaginative and practical ways.
• Prepare and support preparation of samples, standards, reagents, buffers, mobile phases, solutions, and laboratory materials in accordance with approved procedures, protocols, methods, specifications, or project-specific instructions.
• Support the quality control laboratory as a co-stability program coordinator by executing of the Gannet Biochem stability program by coordinating, scheduling testing, reporting, and summarization of results in a cGMP capacity.
• Perform analytical testing and laboratory support activities using established practices and procedures, which may include HPLC/UPLC, GC, UV-Vis, FTIR, titration, Karl Fischer, dissolution, wet chemistry, or other analytical techniques, as assigned and trained.
• Operate, clean, troubleshoot, maintain, and support readiness of laboratory equipment and analytical instrumentation in accordance with SOPs, work instructions, equipment use logs, and applicable safety requirements.
• Analyze simple data, identify obvious trends, review chromatograms, calculations, observations, and laboratory results, and elevate unexpected results or technical issues appropriately.
• Accurately document laboratory work, observations, calculations, instrument use, sample preparation, test results, deviations from expected results, and other required information in notebooks, worksheets, forms, electronic systems, or approved records.
• Compile, summarize, and communicate analytical data, observations, conclusions, task status, and supporting information for review by senior analysts, scientists, project teams, Quality, clients, or management.
• Follow approved test methods, specifications, SOPs, protocols, safety procedures, and laboratory controls; exercise judgment within generally defined practices and policies and seek direction when appropriate.
• Support investigations, deviations, out-of-specification or atypical result evaluations, change controls, CAPAs, laboratory troubleshooting, technical reports, and client deliverables by gathering, evaluating, and organizing data, records, observations, and supporting documentation.
• Draft, review, or revise laboratory documentation, including test methods, protocols, worksheets, reports, SOPs, forms, or other controlled documents, as assigned.
• Train others on simple laboratory tasks, procedures, documentation practices, equipment use, or workflow expectations, as assigned.
• Work with Quality Control, Analytical Development, Process Development, Manufacturing, Quality Assurance, and other internal teams to support timely completion of assigned tasks.
• Maintain laboratory supplies, standards, reagents, samples, retain materials, reference materials, and inventory records in accordance with company procedures.
• Maintain a clean, safe, and organized laboratory work area and comply with applicable company safety, environmental, quality, regulatory, and confidentiality requirements.
• Perform other duties as assigned.
• Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or a related scientific field required.
• Minimum two (2) years of cGMP/cGLP related experience required; experience in Quality Control, analytical testing, pharmaceutical development, CDMO operations, analytical development, or a regulated laboratory environment preferred.
• Ability to use professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Ability to receive no instruction on routine work and general instructions on new assignments.
• Ability to execute complex tasks, analyze simple data, identify obvious trends, and train others on simple tasks.
• Ability to understand limitations of decision-making authority and seek direction when appropriate.
• Ability to document observations and facts so information can be retrieved and understood, and effectively communicate observations and facts verbally to peers.
• Ability to manage own time across multiple tasks when no time or priority conflicts are present.
• Knowledge of analytical chemistry, Quality Control laboratory practices, laboratory safety, sample preparation, solution preparation, calculations, laboratory documentation, cGMP expectations, and data integrity required.
• Hands-on experience with analytical instrumentation such as HPLC/UPLC, GC, UV-Vis, FTIR, titration, Karl Fischer, dissolution, or wet chemistry techniques required.
• 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 required, including weights, measures, ratios, dilutions, concentrations, percentages, and unit conversions.
• Working knowledge of Microsoft Office/365 tools, including Word, Excel, Outlook, and Teams preferred; ability to learn electronic laboratory systems required.
• 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.

Physical Requirements

• Must be able to pass pre-employment drug screening and background check for employment consideration.
• Must be able to lift 25 lbs.
• Must be able to sit or stand for long periods of time.
• Employees must be able to wear a respiratory protection (filtering face piece, ½ face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function.
• Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function.
• Employees must be able to accurately detect color and have 20/20 vision (with/without corrective lenses).