What are the responsibilities and job description for the Microbiologist position at Actalent?
Description:
POSITION DUTIES & RESPONSIBILITIES
1. Perform microbiological methods testing per SOP, and approved protocols.
2. Conduct microbiological method validation including bioburden, sterility, LAL, and virology methods supporting biopharmaceutical, clinical and development products. Responsibility including protocol and report write up
3. Familiarities with microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
4. 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.
5. Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Revises SOP’s affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
Skills:
Molecular biology, Pcr, Elisa, scientist, Biology, analytical skill
Additional Skills & Qualifications:
Minimum Education:
Bachelor's Degree in microbiology or related science degree or technical field.
Minimum Experience : 4 years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
• 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.
• Strong computer skills (Word, Excel, Access, Powerpoint).
• Prior experience in a QC microbiology testing laboratory.
• Ability to work independently with minimum supervision
Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
Demonstrable experience with cGMP and regulatory compliance (FDA, EMA and other international agencies).
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $25 - $33
