QC Laboratory Technician

The details for this position are as follows:


Job Title: ssociate, Quality Control Analytical
Location: Rockville, MD 20850 (Onsite)
Duration: 06 months (Temp. to Perm.)
Pay Rate: $35.00/HR


Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Monday to Friday, 5x8, 8 AM - 5 PM ET
Duration 4 months with possibility of conversion

Job Description:
Hiring Manager Note - just want to be sure that these folks are aware that the ask is for them to support Saturday testing for the next ~2 months, with a day off during the week. Also, that all future FTE positions on the team will be on a 4-day, 10-hour shift (either Wed-Sat or Sun-Wed). Ideally, I'd love to convert everyone at the end of the contract.


Associate, Quality Control Analytical
This position includes occasional weekend work on a rotational basis. Support primarily operates on the following shift, which is subject to change:
Monday to Friday, 5x8, 8 AM - 5 PM ET


Position Summary:
The client is seeking an energetic individual with a cGMP background to join our Quality Control Analytical (QCA) team. The successful candidate will contribute to the advancement of our product pipeline by performing in-process testing, lot release testing, sample management, equipment maintenance , and other assigned lab support tasks. This position is essential for ensuring that the laboratory meets the high standards required for cGMP QCA.


Essential 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 the 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.

Qualifications:

• 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
• The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.
• Experience with sample receipt, storage, and transfer.
• 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 and cell-based methods, PCR (dPCR, qPCR), immunoassays (ELISA), etc.
• Familiar with basic computer applications such as Microsoft Outlook, Word, and Excel.
• Experience operating and maintaining Temperature-Controlled Storage Units.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.

Preferred Qualifications:

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

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund