Job Title: Quality Control Associate IIIJob DescriptionPerform testing and develop methods for flow cytometry and cell analysis. Conduct cell culture and cell counting to ensure quality control. Provide input to improve workflow and laboratory activity, as well as training and oversight to new employees. Execute company and client test methods and procedures to ensure the safety and efficacy of cellular products. Maintain, monitor, and troubleshoot laboratory equipment, and document and report results according to CGMP and GTP guidelines.Responsibilities
Perform testing and develop methods for flow cytometry and cell analysis.
Conduct cell culture and cell counting for quality control.
Provide input to improve workflow and laboratory activity.
Train and oversee new employees.
Execute test methods and procedures to ensure safety and efficacy of cell products.
Maintain, monitor, and troubleshoot laboratory equipment.
Document and report results following CGMP and GTP guidelines.
Organize the lab and manage supplies.
Perform cleanings of laboratory equipment per SOP.
Assist in equipment and method qualification/validation activities.
Cross-train in methods for multiple clients.
Upload data in real time to shared drives or client SharePoint sites.
Prepare reagents and media.
Respond to equipment alarms.
Investigate and troubleshoot malfunctioning equipment.
Investigate and report out-of-specification or non-conforming test results.
Initiate and prepare deviation reports.
Implement corrective and preventive actions.
Document training and execution of shipping test samples.
Complete all documentation according to SOPs in compliance with CGMP and GDP.
Communicate effectively with co-workers, departments, management, and clients.
Assist in training other Quality Control technicians.
Essential Skills
Proficiency in flow cytometry assays and endotoxin testing (5-6 years).
Experience with cell culture (4-5 years).
Experience with test methodology in a quality control setting.
Knowledge of CGMP and GTP guidelines.
Bachelor's or master's degree in a related scientific field.
Experience with microbiology test methods.
Proficiency with microbiology testing and necessary equipment.
Experience in training and leading others in a lab setting.
Experience in a Quality Control laboratory or biopharmaceutical industry (2-4 years).
Additional Skills & Qualifications
Experience maintaining training records and coordinating with Document Control and Training groups.
Experience managing materials and supplies.
Experience ensuring timely issuance, review, and approval of Certificates of Analysis.
Experience initiating, assessing, tracking, and trending deviations, Change Controls, and CAPAs.
Experience maintaining an inspection-ready state laboratory.
Experience as a subject matter expert during audits/inspections.
Experience leading or co-leading client projects.
Experience in clinical laboratory, microbiology, hematology, blood banking, or immunology.
Proficiency with computer software such as Microsoft Office and Visio.
Work EnvironmentThe position operates in an aseptic quality environment. The work schedule is primarily 1st Shift (Tuesday - Saturday, 7am-3:30pm) with flexibility required. Training will occur Monday to Friday, 8am-4:30pm, for the first 2-3 months. All methods and SOPs are electronic-based, while testing and documentation are paper-based. The role involves working closely with scientists and associates to advance methods and will require flexibility due to the nature of cell and gene therapy.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.