Job Title: Quality Control Associate ScientistJob DescriptionPerform testing to help develop methods for flow cytometry and relevant analysis. Conduct cell culture and cell counting to analyze for quality control. Assist in the analysis for flow methods and complexity testing. Provide input to improve workflow and laboratory activity and offer training and oversight to new employees.Responsibilities
Execute all company and client test methods and procedures for cellular products to ensure safety and efficacy.
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 or client procedures under CGMP and GTP guidelines.
Conduct proficiency testing under direct supervision.
Organize the lab and put supplies away in an organized manner.
Clean laboratory equipment (incubators, refrigerators, freezers, etc.) per SOP.
Assist in equipment and method qualification/validation activities.
Cross-train in methods for multiple clients to increase lab efficiency.
Upload data in real-time to shared drives or client SharePoint sites.
Prepare reagents and media.
Respond to equipment alarms using the Linc Alarm Report system.
Provide input on troubleshooting malfunctioning equipment.
Investigate out-of-specification, out-of-trend, aberrant, or non-conforming test results.
Initiate, investigate, and prepare deviation reports with input from the supervisor.
Implement corrective and preventive actions as applicable.
Document training and execution of shipping test samples to contract laboratories.
Complete all documentation according to written SOPs in compliance with CGMP and GDP.
Communicate effectively with co-workers, departments, management, and clients.
Assist in the training of other Quality Control technicians.
Essential Skills
1-2 years of experience performing flow cytometry assays and endotoxin testing.
1-2 years of cell culture experience.
Experience with test methodology within a quality control setting.
Experience with microbiology test methods and necessary equipment.
Experience in a CGMP/GTP environment.
Proficiency with computer software such as Microsoft Office and Visio.
Additional Skills & Qualifications
Bachelor's or Master's degree in a related scientific field.
Experience in clinical laboratory, microbiology, hematology, blood banking, or immunology.
Prior industrial experience in cell count methodologies preferred.
Prior academic and/or industrial cell therapeutic experience preferred.
Minimum 2-4 years of experience in a Quality Control laboratory setting or within the biopharmaceutical industry.
Work EnvironmentShift: 2nd shift- Sun-Thurs (2:30 PM - 11:00 PM). Training is M-F 8:00 AM - 4:30 PM. Flexible work environment, part of the Analytical Team, working in an aseptic quality environment. Associates must be adaptable due to potential delays in cell and gene therapy processes. The role involves cleaning the lab, setting up equipment, and performing controls for sample testing.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.
