Duration: 6 to 12 months with Possibility of Extension.
Pay rate : $30-34/hr
Description
Quality Control Microbiology
Perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, development product release.
Position Summary- This position is to support related QC Assay testing/validation for Inspire-01 project.
Position Duties & Responsibilities
Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical and development products. Responsibility including protocol and report write up.
Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
Investigates questionable test results, writes protocol deviation report (PDR), investigation/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Write protocols, revises SOP?s affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
Prior experience in a QC microbiology testing laboratory.
Ability to work independently with minimum supervision.
Requirements/Preferences
Education Requirement(s):
Minimum Education bachelors degree in microbiology or related science degree or technical field. Minimum Experience 2+ years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.