Project Coordinator, Microbiology

Posted on Jul 30, 2020 by Renaissance LLC

Lakewood, NJ 08701
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Renaissance LLC

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.


Overview

The Microbiology Project Coordinator directly supports in the daily management of multiple projects for our healthcare partners. Specific responsibilities include the creation and maintenance of laboratory timelines and documentation review such as protocols and applicable change controls for the projects. As the laboratory point of contact with the Project Managers and Project Coordinators the individual needs to maintain strong professional relationships with them through setting realistic expectations and timely communications.

Responsibilities

• Participate in internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare partners.

• Review and evaluate method transfer/verification/validation protocols, client/vendor methods for the method transfer activities.

• Gather information and contribute to the writing and review of protocols.

• Attend internal and client meetings to provide communication of progress and issues.

• Responsible for writing and revising SOP's, investigations, deviations, technical reports, etc.

• Support regulatory submission information gathering.

• Identify opportunities to improve processes/systems.
  • Perform assessments on new components and materials, as required.
  • Properly document any changes to laboratory timelines and follow up to ensure approval of same by the client and internal team members.
  • Self-develop to be able to move into positions of greater responsibility as opportunities occur.
  • Perform other duties and responsibilities as assigned.


Qualifications

Bachelor's degree required with a minimum of 5 years of Microbiology experience in pharmaceutical industry pr a Master's degree with a minimum of 3 years required.

Reference: 918727243

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