Associate QC Chemist

Samsung Biologics; 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 in Rockville, MD is seeking an Associate QC Chemist to perform routine analytical testing of in-process, release, and stability samples under cGMP.

You will operate instruments, ensure data integrity, and contribute to SOP maintenance and investigations, with a 1–3 year background in a pharmaceutical or biotech lab.

Qualifications

• Bachelor’s degree required in a related scientific discipline.
• 1–3 years of experience in a cGMP pharma/biotech lab.
• Strong knowledge of analytical and biochemical testing techniques.

Responsibilities

• Perform and document routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples per SOPs and cGMP.
• Operate, calibrate, maintain, and troubleshoot QC laboratory instruments and equipment.
• Apply knowledge of cGMP, FDA regulations (21 CFR), ICH guidelines to ensure lab compliance.
• Review laboratory procedures and identify opportunities to improve 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 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.

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline

Job description

Associate QC Chemist

• 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.

Qualifications

• 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.

The anticipated salary range for this position in Maryland is $67,072 to $89,430 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.

Benefits:

• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment