QC Laboratory Technician

Location: Rockville, MD 20850 (Onsite) • 6-month contract with possibility of permanent hire • $35.00/hour

Applicants must be authorized to work for any U.S. employer; sponsorship is not available.

About the role

The client is seeking an energetic individual with a cGMP background to join the Quality Control Analytical (QCA) team. The successful candidate will perform in-process testing, lot release testing, sample management, equipment maintenance, and other lab support tasks to ensure the laboratory meets cGMP standards.

Note: For the next ~2 months, weekend (Saturday) testing support is required, with a weekday off in return. Future full-time positions on this team will operate on a 4-day, 10-hour shift schedule (either Wed–Sat or Sun–Wed).

Responsibilities

• Perform cGMP release testing (e.g., cell counting, flow cytometry, ELISA, cell-based cytotoxicity, dPCR) for cell therapy products and in-process samples.
• Perform in-process flow cytometry testing to support manufacturing operations.
• Support vialing and cryopreservation of in-process characterization samples.
• Receive, verify, label, store, and track samples, controls, and reagents to ensure traceability and timely transfer to testing laboratories, using paper and electronic systems and operating temperature-controlled units.
• Support laboratory cleaning and equipment maintenance activities.
• Support cell line thawing, passaging, and maintenance.
• Author and/or review analytical test results and technical documents, including analytical method qualification protocols and reports, and standard operating procedures (SOPs).
• Document activities, record observations, and complete all paperwork in accordance with cGMPs, SOPs, and protocols.
• Execute protocol-driven method qualification, verification, and validation, and support analytical technology transfer and method lifecycle management activities.
• Escalate and document invalid, OOS/OOT results; support deviations, CAPAs, and change controls; and contribute to investigations as needed.
• Follow Safety, Health, and Environmental procedures, maintain a safe and organized laboratory environment, and use appropriate PPE and aseptic/biocontainment practices.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree, preferably in Biology or equivalent, with 1–2 years of relevant cGMP laboratory experience; or Associate’s degree, preferably in Biology or equivalent, with 2–3 years of relevant cGMP laboratory experience.
• 0–3 years executing routine and non-routine analysis for cGMP lot release and stability testing using techniques including, but not limited to, cell culture, flow cytometry, cell-based methods, PCR (dPCR, qPCR), immunoassays (ELISA), etc.
• Experience with sample receipt, storage, and transfer.
• Experience operating and maintaining temperature-controlled storage units.
• Familiarity with basic computer applications such as Microsoft Outlook, Word, and Excel.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced team setting.

Preferred Qualifications

• Experience in Cell or Gene Therapy.
• Proficiency in analytical techniques such as flow cytometry, qPCR, dPCR, cell-based potency, and/or ELISA.

Benefits

• Medical, vision, and dental insurance plans.
• 401k retirement fund.

Schedule

• Monday to Friday, 8 AM – 5 PM ET (temporary Saturday testing for ~2 months, with a weekday off).
• Future full-time roles will follow a 4-day, 10-hour shift (Wed–Sat or Sun–Wed).