Job Title: Quality Control Associate IIJob DescriptionPerform testing to help develop methods for flow cytometry and cell analysis. Perform cell culture and cell counting in order to analyze for quality control. Help perform analysis for flow methods and complexity testing. Provide input to improve workflow and laboratory activity. Provide input and proficiency in relevant testing. Provide training and some oversight to new employees on the team.Responsibilities
Perform the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and efficacy of different cell populations.
Perform maintenance, monitoring, and troubleshooting of pertinent equipment.
Perform maintenance of laboratory equipment including routine start-ups and shutdowns.
Test, document, and report results for products or materials following company and/or client procedures in accordance with CGMP and/or GTP guidelines.
Perform client proficiency testing under direct supervision as applicable.
Organize the lab and put supplies away in a neat and organized manner.
Perform cleanings of laboratory equipment (incubators, refrigerators, freezers, etc.) per SOP.
Assist in equipment and method qualification/validation activities as needed.
Crosstrain in methods for multiple clients to increase efficiency in the lab for all client projects.
Upload data in real time onto shared drive or client SharePoint sites.
Prepare reagents and media.
Respond to equipment alarms in the Linc Alarm Report system.
Provide input based on knowledge and experience with troubleshooting malfunctioning equipment.
Investigate out-of-specification, out-of-trend, aberrant, and/or non-conforming test results.
Initiate, investigate, and prepare deviation reports with input from assigned supervisor.
Brainstorm and implement corrective and preventive actions, as applicable.
Document training and execution of shipping test samples to contract laboratories for testing.
Complete all documentation according to written Standard Operating Procedures in accordance with CGMP and GDP.
Communicate effectively with other co-workers, departments, management, and clients.
Assist in the training of other Quality Control technicians.
Essential Skills
2-4 years of experience performing flow cytometry assays and endotoxin testing.
3-4 years of experience with cell culture.
Experience with test methodology within a quality control setting.
Experience with microbiology test methods.
Proficiency with microbiology testing and use of necessary equipment.
Experience helping to train and lead others in the lab.
Maintains training records and coordinates records retention with Document Control and Training groups.
Manages materials and supplies.
Ensures timely issuance, review, and approval of Certificates of Analysis.
Initiates, assesses, tracks, and trends deviations, Change Controls, and CAPAs.
Applies expertise in compliance requirements to maintain an inspection-ready state laboratory.
Participates as a subject matter expert during audits/inspections.
Serves as a lead and/or co-lead for one or more client projects.
Proficient 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 a CGMP/GTP environment preferred.
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 EnvironmentThe work environment is an aseptic quality environment. The position requires flexibility due to the nature of cell and gene therapy work. You will be working on the 2nd shift from Tuesday to Saturday (2:30 PM - 11:00 PM) with initial training from Monday to Friday (8:00 AM - 4:30 PM) for the first 2-3 months. All associates should be flexible as sample processing can be delayed. Morning shifts will involve cleaning the lab, setting up equipment, and performing controls to ensure readiness for sample processing. All methods and SOPs are electronic-based, while testing and documentation are paper-based.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 [email protected] (%[email protected]) for other accommodation options.