Microbiologist II

UPM Pharmaceuticals is an independent, highly experienced and award winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability. Currently, UPM is accepting open applications for a Microbiologist 2 within the company.

Summary:

Performs routine microbiological quality control testing of pharmaceutical products and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. Assists in special testing studies of experimental, investigative, validation studies and problem solving nature. Participates in programs to achieve departmental objectives; records and reports results; notes unusual results and notifies supervisor for evaluation. This position requires a continuation of training and learning to become proficient with routine testing procedures, compendial methods, cGMP and associated SOPs.

Essential Duties and Responsibilities:

The essential functions of this position may include, but are not limited to:

1. Performs routine microbiological testing of raw material, in-process, finished product and stability following approved specification and Standard Operating Procedures (SOPs). This may include but is not limited to antibiotic testing, bioburden/microbial limit testing, antimicrobial effectiveness testing, water testing, environmental monitoring, microbial isolation and identification technique, sterility and endotoxin testing.

2. Completes testing with a high degree of efficiency, reliability and accuracy.

3. Maintains the Microbiology Laboratory. This may include but is not limited to maintenance, calibration and use of standard laboratory equipment.

4. Logs samples received into the laboratory to assess their integrity upon receipt.

5. Performs assigned work in timely and safe manner conforming to regulatory, company and compendial requirements.

6. Records and reports test data correctly, completely and accurately within company and departmental policies and guidelines. Notifies supervisor of unusual results for evaluation.

7. Actively assumes and demonstrates responsibility in learning practical laboratory skills and a thorough knowledge of microbiological theories, methodologies and procedures.

8. Acquires complete knowledge and understanding of company and departmental policies pertaining to cGMP, cGLP, safety, health, security and departmental operation. Complies with company and departmental regulations, policies and guidelines in performance of the job.

9. Recognizes problem within scope of the job and promptly and clearly communicates them to supervisor. Follows directions and demonstrates proper judgment when a deviation occurs.

10. Initiates Laboratory Investigations (LIR) and Notices of Events (NOE). Reviews OOS and unusual test/equipment data with management or senior staff. Completes LIR or NOE under the direction of management and advisement of more experienced laboratory staff

11. Recognizes trends, deviations, problems and promptly reports them to laboratory management. Follows directions and demonstrates proper judgment when a deviation occurs.

12. Participates in inventory control. Maintains a neat and orderly workplace, adhering to all laboratory disinfection policies.

13. Assist in performing experiments related to problem solving for the Microbiology department, under the direction of more experienced analysts and/or laboratory management.

14. Trains less experienced employees on new methods or procedures in the lab, under the direction of laboratory management.

15. Assists in microbial method validation, coordinates the materials required for method, process and system validations as under the direction of more experienced analysts and/or laboratory management.

Education/Experience:

Bachelor’s Degree in Microbiology or related science field and 2 to 4 years related experience; or an equivalent combination of education and experience/training. Bachelor’s Degree in Microbiology or related science field and 2 to 4 years related experience; or an equivalent combination of education and experience/training.

Job Type: Full-time

Pay: $20.00 - $30.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 8 hour shift

Work Location: One location

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