QC Scientist-Micro

Job Title: QC Scientist-Micro
Location: Princeton, NJ
Type: Contract To Hire
Contractor Work Model: Onsite – onsite

Responsibilities

• Perform sterility testing, endotoxin testing, microbial identification, and routine microbiological testing on raw materials, in-process samples, and finished products
• Conduct compendial tests including BacT assay, Endotoxin, and Mycoplasma assay
• Execute trend analysis of EM and sterility data and write monitoring reports. Suggest/initiate resolution plan based on risks identified
• Support ongoing EMPQ, cleaning and disinfection, and improvement of aseptic control. Conduct environmental monitoring of manufacturing and laboratory areas
• Participate in investigations related to microbiological deviations, out-of-specification results, and non-conformances. Support CAPA, Change Control, and change action
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Research & Development
• Support developing and implementing the site Microbial Control Strategy from incoming raw materials through final product release. Perform growth promotion as release testing
• Analyze and interpret test results, documenting findings in compliance with SOPs and regulatory requirements
• Maintain the QC microbiological lab, ordering reagents, and logbook. Perform other duties as assigned

• 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.
• Experience 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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