Sterile Product Microbiologist
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Job Location:
Palm Harbor, FL - USA
Yearly Salary:
USD 52000 - 69000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Microbiologist is a professional position which performs quality control testing on samples received from clients trains new staff to perform quality control tests recommends improvements to procedures and processes for enhanced compliance and efficiency and is responsible for general upkeep and maintenance of laboratory and its quality systems.
Duties and responsibilities
Performs Quality Control Testing on clients samples including but not limited to USP <71> Sterility Testing ScanRD/ rapid microbiological methodology container closure integrity testing endotoxin testing microbial limits and preservative efficacy testing.
Immediately reports any Out of Specification (OOS) results or Deviations to test methods to management and aids in the investigation.
Composes and reviews SOPs and protocols as necessary to comply with changes in client needs compendia and laboratory specifications.
Assisting in training of new testing personnel Microbiology Technicians and Laboratory Assistants.
Updates customers if directed to do so tiy laboratory management.
Fellows all safety precautions and uses appropriate PPE where required.
Documents all data in compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) as outlined in 21CFR210 and211.
Logs samples into laboratory as needed.
Maintains inventory and list supplies to be ordered.
Receives incoming materials in proper manner.
Prepares microbiological media and perform the requisite quality control tests on prepared media.
Maintains culture collection; prepares growth support culture and other inoculation cultures
Performs all quality functions necessary to run an efficient and effective laboratory such as: clean glassware monitor temperatures disinfection of hoods and benches processing waste (daily garbage biohazardous andchemical waste) performing environmental monitoring in laboratory and mopping floors.
Qualifications Microbiologist for Sterile Product Testing should have at least a bachelors degree from an accredited university in biology or chemistry. Proven experience in aseptic technique clean room gowning good documentation practices and basic microbial culture techniques is required.
As part of our commitment to maintaining a safe and compliant work environment all offers of employment are contingent upon successful completion of a background check and drug screening. These screenings are conducted to ensure the safety and integrity of our team and operations. By applying for this position you acknowledge and agree to participate in these screenings and understand that employment is subject to their satisfactory completion.
Key Skills
- Laboratory Experience
- Aseptic Technique
- Virology
- Clinical Laboratory Experience
- FDA Regulations
- Laboratory Procedures
- PCR
- Microbiology
- Quality Control
- GLP
- cGMP
- Laboratory Information Management Systems
About Company
FOCUS Laboratories provides microbiological testing and consultation services to the pharmaceutical, cosmetic, biotechnology, and medical device industries.
