QC Analytical Associate II

Job Description:
The Quality Control Analytical Associate II (2nd Shift, Sunday-Thursday, (2:30PM-11:00PM) serves as a support role in clinical and commercial production. The QC Analytical Associate II will assist with process check points, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility.
Essential Functions and Responsibilities:

• Under the direction of the Supervisor, QC Analytical, the responsibilities of the QC Analytical Associate II include, but are not limited to:
• 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.
• Assist with 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.
• Basic leadership or mentoring skills, including supporting and training junior staff.
• Strong organizational skills with the ability to manage multiple tasks and priorities effectively.

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
• Previous academic and/or industrial experience in cell therapy and/or cell and gene therapy is highly desirable.
• Experience with QC assays such as complete blood count (CBC), cell count and viability, and basic flow cytometry knowledge is a plus.
• Minimum of 2 years of experience in a Quality Control laboratory or biopharmaceutical industry setting is preferred.