Associate QC Chemist

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

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

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.