Microbiologist III

Position – Microbiologist III

Pay Rate: $60K – $75K USD Yearly

Location: Oklahoma City, OK (On-site)

Job Description

Summary

This is an advanced-level position for a highly motivated and experienced Microbiologist. The role offers a wide range of responsibilities, progressively increasing in complexity; independently troubleshoot and resolve testing and organizational issues and analyze and interpret data to ensure accuracy and adherence to USP and regulatory guidelines. May also be trained to assist in Data Review as needed.

Working independently with limited supervision, performing complex microbiological testing of compounded sterile and non-sterile pharmaceuticals. Performs Endotoxin tests on non-sterile pharmaceuticals, taking on advanced isolation of specific microorganisms and evaluating causes of contamination sources, and reviewing test data of junior department members for accuracy.

Furthermore, the Microbiologist III will take on mentoring junior staff, manage client communication, and participate in cross-departmental discussions, providing valuable expertise in developing processes and procedures for wide and complex technical and operations issues. May at times lead strategic projects.

Essential Functions

1. Completion of various microbiology tests including compounded sterile and non-sterile pharmaceuticals.
2. Perform Bacterial Endotoxin Tests for Category 2 and 3 compounded sterile preparations and use endotoxin challenge vials to determine if drug products are non-pyrogenic.
3. Review Closed and Open Membrane Filtration test data to check for quality control of Sterility testing for clients.
4. Use different Growth Media specific to the goal of the test being performed to identify and screen for specific organisms that would be particularly dangerous for each product and/or dosage form.
5. Use techniques such as gram stain reaction, morphology, and metabolic reaction to isolate microorganisms for accurate identification and testing, and to determine causes of contamination in client samples.
6. Perform Container Closure Integrity Testing (CCIT) on IV bags, syringes, cassettes, and vials to determine the entry of microorganisms.
7. Participate in discussions with cross-department personnel and external agencies to assess advanced technical and operational issues from sample and project testing to results and SOP statements.
8. Answer client FAQs and advanced non-routine complex calls that involve detailed analysis of testing and results, via email or phone, promptly and professionally.
9. Mentor and assist in coaching and development of junior-level laboratory personnel in performing tests and understanding protocols.
10. Strict adherence to Standard Laboratory Operations, Quality Management Systems (QMS), and Current Good Manufacturing Practice (cGMP) guidelines.
11. Adhere to, use, and maintain Personal Protective Equipment (PPE) and Laboratory Safety Equipment and identify hazards that may arise.
12. Oversee chemicals with classifications of Hazardous, Toxic, Corrosive, Flammable, or Oxidizing.
13. Ability to wear a full-face respirator in addition to standard Personal Protective Equipment.
14. Complete all safety training including but not limited to OSHA, departmental SOPs, and company compliance.
15. May also be trained to assist in Data Review as needed.
16. Adherence to all company safety standards, policies, procedures, and protocols.
17. Maintain adequate attendance as per department and company expectations.
18. Perform all other duties as assigned.

Key Skills, Abilities & Success Factors

1. Knowledge of Microbiology and Testing Methodology.
2. Technical Capacity: Ability to use various sensitive laboratory equipment.
3. Analytical/Problem-Solving Skills: Ability to analyze and interpret data from tests including sterility, fungal, and endotoxins.
4. Detail Proficiency: Strong attention to detail and accuracy.
5. Organization Skills: Ability to manage multiple samples with strict controls.
6. Collaboration Proficiency: Ability to work independently and within a team environment.
7. Professional Verbal and Written Communication.
8. Time Management: Ability to meet time-sensitive deadlines.
9. Digital Literacy: Proficiency in MS Office and LIMS.
10. Intercultural Sensitivity.

Minimum Qualifications

Education:

• Bachelor’s degree in Microbiology or equivalent Diploma

Work Experience:

• 2 years of experience in a microbiology laboratory setting
• 2 years of experience in performing detailed microbiology tests

Preferred Qualifications

Education:

• Master’s degree in Microbiology or equivalent Diploma

Work Experience:

• 3 years of experience in a microbiology laboratory setting
• Experience with microbiology testing methodology
• Experience with Laboratory Information Management Systems (LIMS)
• Experience in the Pharmaceutical Industry

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