QC Chemist: Compliance, Methods & Data Integrity

Samsung Biologics RKV; Rockville (MD); On-site; USD 67,000 - 89,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental and vision benefits

Job summary

Samsung Biologics is seeking an Associate QC Chemist to perform routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples in accordance with SOPs, test methods, and cGMP requirements.

You will operate, calibrate, maintain, and troubleshoot QC laboratory instruments, review procedures, and support investigations and method qualifications while upholding ALCOA+ data integrity and safety standards.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related field.
• 1–3 years in a cGMP pharma/biotech lab.
• Familiarity with FDA cGMP regulations and data integrity practices.
• Strong writing, problem-solving, and organizational skills.
• Ability to work independently and in a fast-paced QC lab.

Responsibilities

• Perform and document routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples in accordance with SOPs, test methods, and cGMP requirements.
• Operate, calibrate, maintain, and troubleshoot QC lab instruments and equipment to ensure compliance and efficiency.
• Review lab procedures and identify opportunities to improve compliance and data integrity; author and maintain SOPs and controlled documents.
• Assist with investigations, deviation assessments, OOS/OOT, root cause analyses, and method troubleshooting.
• Support reagent qualification and requalification activities; participate in analytical method qualification, validation, and transfer.
• Maintain contemporaneous documentation and support audit readiness through self-inspection activities.

Skills

cGMP knowledge

Technical writing

Problem-solving

Education

Bachelor's degree in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences or related

Job description

Samsung Biologics is seeking an Associate QC Chemist to perform routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples in accordance with SOPs, test methods, and cGMP requirements.

You will operate, calibrate, maintain, and troubleshoot QC laboratory instruments, review procedures, and support investigations and method qualifications while upholding ALCOA+ data integrity and safety standards.