Associate QC Chemist

Samsung Biologics•Rockville, MD

20h•Onsite

About The Position

Perform and document routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples in accordance with approved SOPs, test methods, and cGMP requirements. Operate, calibrate, maintain, and troubleshoot QC laboratory instruments and equipment in a compliant and efficient manner. Apply knowledge of cGMP, FDA regulations (21 CFR), ICH guidelines, and other applicable regulatory requirements to ensure laboratory compliance. Review laboratory procedures and identify continuous improvement opportunities to enhance compliance, efficiency, and data integrity. Author, revise, and maintain laboratory SOPs, protocols, and controlled documents as required. Assist with laboratory investigations, deviation assessments, OOS/OOT investigations, root cause analyses, and analytical method troubleshooting. Support critical reagent qualification and requalification activities. Participate in analytical method qualification, validation, verification, transfer, and compendial method implementation activities. Maintain accurate, complete, and contemporaneous documentation in accordance with ALCOA+ and data integrity principles. Adhere to all laboratory safety requirements and actively support a safe working environment. Serve as a trained Self-Inspection Auditor and participate in at least 25% of departmental self-inspection activities to support audit readiness and continuous compliance.

Requirements

Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
1-3 years of experience in a cGMP pharmaceutical, biotechnology, or biologics laboratory environment.
Working knowledge of analytical and biochemical testing techniques and laboratory instrumentation.
Familiarity with FDA cGMP regulations, 21 CFR Part 210/211, data integrity requirements, and laboratory compliance practices.
Strong technical writing, problem-solving, and organizational skills.
Ability to work independently as well as collaboratively in a fast-paced QC laboratory environment.

Responsibilities

Perform and document routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples in accordance with approved SOPs, test methods, and cGMP requirements.
Operate, calibrate, maintain, and troubleshoot QC laboratory instruments and equipment in a compliant and efficient manner.
Apply knowledge of cGMP, FDA regulations (21 CFR), ICH guidelines, and other applicable regulatory requirements to ensure laboratory compliance.
Review laboratory procedures and identify continuous improvement opportunities to enhance compliance, efficiency, and data integrity.
Author, revise, and maintain laboratory SOPs, protocols, and controlled documents as required.
Assist with laboratory investigations, deviation assessments, OOS/OOT investigations, root cause analyses, and analytical method troubleshooting.
Support critical reagent qualification and requalification activities.
Participate in analytical method qualification, validation, verification, transfer, and compendial method implementation activities.
Maintain accurate, complete, and contemporaneous documentation in accordance with ALCOA+ and data integrity principles.
Adhere to all laboratory safety requirements and actively support a safe working environment.
Serve as a trained Self-Inspection Auditor and participate in at least 25% of departmental self-inspection activities to support audit readiness and continuous compliance.