QC Analytical Associate II

Essential Functions And Responsibilities

• Assist with process checkpoints, stability, in-process, and release analytical testing, including but not limited to cell count, viability, endotoxin, flow cytometry, complete blood count (CBC), ELISA, etc.
• Accurately execute all company and/or client test methods and procedures for cellular products to ensure safety and efficacy of different cell populations.
• Perform maintenance, monitoring, and troubleshooting of laboratory equipment, including routine start-ups and shutdowns.
• Test, document, and report results for products or materials following company/client procedures and cGMP guidelines.
• Perform client proficiency testing under direct supervision, as applicable.
• Maintain and inventory QC materials and laboratory supplies; organize and store supplies systematically.
• Perform cleaning and routine maintenance of laboratory equipment such as incubators, refrigerators, and freezers according to SOPs.
• Auxiliary in equipment and method qualification/validation activities as needed.
• Cross-train on methods for multiple clients (up to four) to increase laboratory efficiency across projects.
• Upload data in real time to shared drives or client SharePoint sites.
• Prepare reagents and media according to client or general procedures.
• Provide input on troubleshooting malfunctioning equipment based on knowledge and experience.
• Investigate out-of-specification (OOS), out-of-trend (OOT), aberrant, and non-conforming test results.
• Initiate, investigate, and prepare deviation reports with supervisor input.
• Participate in brainstorming and implementing corrective and preventive actions (CAPAs) when applicable.
• Manage client-specific QC data and documentation on shared drives or client SharePoint sites.
• Document training and oversee execution of shipping test samples to contract laboratories for testing.
• Complete all documentation according to SOPs, Current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP).
• Communicate effectively with co-workers, departments, management, and clients.
• Perform and assist in training other Quality Control technicians.
• Maintain training records and coordinate records retention with Document Control and Training groups.
• Manage QC materials and supplies.
• Ensure timely issuance, review, and approval of Certificates of Analysis, and timely closure of batch records, deviations, and CAPAs.
• Initiate, assess, track, and trend deviations, Change Controls, and CAPAs.
• Apply expertise in compliance requirements to maintain an inspection-ready laboratory.
• Participate as a subject matter expert during audits and inspections.
• Serve as lead or co-lead for one or more client projects, including leading QC meetings with clients and addressing concerns with QC management assistance.
• Track program status via client trackers.

Knowledge, Skills & Ability

• Proficient with computer software including Microsoft Office and Visio.
• Solid understanding of cGMP regulations, quality systems, and compliance standards relevant to QC analytical testing.
• Proficient in executing a variety of analytical test methods (e.g., cell count, viability, ELISA, flow cytometry, endotoxin testing) with accuracy and attention to detail.
• Experience with laboratory equipment maintenance, troubleshooting, and calibration activities.
• Competent in data documentation and management using electronic systems such as LIMS and Microsoft Office applications.
• Strong problem-solving skills with the ability to investigate deviations, out-of-specification results, and support CAPA implementation.
• Effective verbal and written communication skills to interact with team members, management, clients, and auditors.
• Ability to work collaboratively in a team and support cross-training initiatives.
• Demonstrates initiative, flexibility, and adaptability to changing priorities and client needs.

Education & Experience

• Bachelor's degree (BA/BS) in a scientific discipline or relevant field is required.
• Prior experience in QC laboratories, clinical laboratories, microbiology, hematology, blood banking, or immunology within a cGMP/GTP-regulated environment is preferred.
• Experience with flow cytometry is a plus.
• Previous academic and/or industrial experience in cell therapy and/or cell and gene therapy is highly desirable.
• Minimum of 2 years of experience in a Quality Control laboratory or biopharmaceutical industry setting is preferred.