QC Associate I
3 days ago
Job Description
Perform testing to help develop methods for flow cytometry and analysis. Perform cell culture and cell counting 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. Perform the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations. Perform maintenance, monitoring, and troubleshooting of pertinent equipment, including routine start-ups and shutdowns. Test, document, and report results for products or materials following company and/or client procedures under 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. Perform and assist in equipment and method qualification/validation activities as needed. Crosstrain in methods for multiple (up to 4) clients to increase efficiency in the lab for all client projects. Upload data in real-time onto shared drives or client SharePoint sites. Perform reagent and media preparation. Respond to all equipment alarms in the View Linc Alarm Report system. Provide input based on level of 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 Current Good Manufacturing Practices (CGMP) and Good Documentation Practices (GDP). Communicate effectively with co-workers, departments, management, and clients. Perform and assist in the training of other Quality Control technicians.
Hard Skills- 1-2 years experience performing flow cytometry assays and endotoxin testing
- Nuclear testing
- 1-2 years with cell culture experience
- Experience with test methodology within a quality control setting
- Flexibility
- Effective communication
- Troubleshooting
- Training and oversight
This is a Contract-to-Hire position with a duration of 6 Month(s).
Work SiteThis is a fully on-site position in Allendale, New Jersey.
Work EnvironmentShift: 2nd shift - Sun-Thurs (2:30pm-11:00pm). Training is M-F 8:00am-4:30pm. This person will be part of the Analytical Team and will report to a quality control manager. They will work alongside scientists and Associate III to move methods forward. They will be working within an aseptic quality environment. Flexibility is crucial as cell and gene therapy can be delayed. Processing the samples in a quality-controlled environment.
About ActalentActalent 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 & InclusionAt 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 for other accommodation options.
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