Job Title: Microbiologist Location: Piscataway, NJHours/Schedule: M-F, 8-5Type: Direct, $75/k-$85/kOverviewOur client is a fully-integrated biopharmaceutical company with global R&D, clinical, regulatory, and manufacturing capabilities.Responsibilities
Coordinates microbiological testing, release of product and testing for validation protocols.
Performs organism identification.
Performs technical review of batch filling records to ensure quality of aseptic processes.
Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests.
May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives.
Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
Performs other functions as required or assigned
Complies with all company policies and standards
Requirements
Bachelor’s degree
3-8 years relevant experience
EM (environmental monitoring)
Strong experience with Aseptic Techniques
Experience with bioburden and endotoxin testing.
Experience with WFI sampling (water for injection sampling) "water testing"
Experience with Veeva Vault a plus
Experience with Autoclave expected
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.