Quality Control Analytical Associate

Position Summary

• Seeking an energetic individual with cGMP background to join our Quality Control Analytical (QCA) team.
• 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.
• This position includes occasional weekend work on a rotational basis.
• Support primarily operates on the following shift, which is subject to change:
• 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.
  
  

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.
• Experience in Cell or Gene Therapy.
• Well versed in various analytical techniques such as flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.
• Monday to Friday, 5x8, 8AM - 5PM ET
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.