QC Scientist-Bioanalytical

Job Title: QC Scientist-Bioanalytical
Location: Princeton, NJ
Type: Contract To Hire
Compensation: (not provided)
Contractor Work Model: Onsite – onsite
Hours: 40.0

Responsibilities

• Perform routine and non-routine bio-analytical testing on raw materials, in-process samples, and finished products
• Utilize various techniques such as ddPCR, Flow Cytometry, ELISA, Viability assay, and cell culture
• Analyze and interpret data from bio-analytical assays, ensuring accuracy and compliance with SOPs and regulatory requirements
• Write and revise SOPs, forms, and test records. Write deviations and CAPAs as required. Initiate Change Controls and complete necessary documentation
• Support Cell Therapy technology transfer activities and validation/qualification of analytical methods, including training on new methodologies, setup of new equipment, generation of method SOPs, and execution of validation/qualification protocols
• Provide instrumentation care, maintenance, troubleshooting, and data interpretation. Collaborate cross-functionally with manufacturing and quality assurance staff to resolve issues. Support the QC lab tracking, trending system, and programs that assist in the testing, monitoring, and evaluation of assay performance and efficiency

Requirements

• BS or MS in microbiology, Biochemistry, Analytical Chemistry, Molecular Biology, or a related field
• Minimum 4-7 yrs. exp. in a microbiology and/or bio-analytical laboratory, preferably in a pharmaceutical, biotechnology, or related industry. If no degree they must have 10+ yrs. relevant experience
• Strong understanding of microbiological and bio-analytical techniques and principles, including aseptic techniques, ddPCR, Flow Cytometry, ELISA, Viability assay, and cell culture exp. with method development and validation in a regulated environment
• Familiarity with regulatory requirements (e.g., FDA, EMA) and cGMP guidelines
• Proficiency in using laboratory equipment and software for data analysis
• Ability to troubleshoot and solve technical problems related to microbiological and bio-analytical testing
• Familiarity with quality management systems and continuous improvement processes

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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