Sr. Microbiologist, Quality Control
About The Position
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: As a Sr. Microbiologist, Quality Control, you will lead the way in ensuring compliance with environmental regulations and Good Manufacturing Practices (GMP) by performing microbiological testing in a biopharmaceutical manufacturing organization. You will utilize state-of-the-art technology to monitor air, water, and surfaces for potential contaminants, inoculate microbial cultures for growth promotion testing, and perform bioburden testing. You will also review and trend data, generate charts, and maintain inventory of supplies. Your work will contribute to the production of life-saving biopharmaceuticals, making a positive impact on public health and the environment.
Requirements
- B.S. in Microbiology or related field with a minimum of 4-5 years of experience in a GMP facility working in a Microbiology lab; or master's degree in microbiology or related field with a minimum of 1-3 years of experience.
- Experience in performing the following tasks on a routine basis:
- Bioburden testing of water systems, raw materials, in-process materials/components, and finished product.
- Gram staining and experience with colony morphology.
- Aseptic microbiological techniques used in the microbiology lab to prevent contamination and cross-contamination.
- Trend Report and/or Protocol writing.
- Support Investigations to determine root cause and corrective action.
- Growth promotion testing.
- Knowledge of aseptic techniques and behavior.
- Must have knowledge of cGMP and should have necessary skills working in controlled environments.
- Experience with LIMS (preferable Labware and or MODA)
- Working knowledge of USP, EP, and Annex 1.
Responsibilities
- Perform bioburden testing of water and in-process samples per USP, EP requirements, and gram staining of recovered microorganisms.
- Read EM plates and document results on relevant forms.
- Perform growth promotion testing.
- Perform Trending in LIMS (MODA or Labware).
- Maintain inventory of department supplies and place purchase orders.
- Inoculate microbial cultures for growth promotion testing.
- Prepare cultures to send out for identification when needed.
- Support investigations for EM out-of-limit results, including notification and re-testing of alert and action OOLs.
- Perform data review of environmental monitoring and assist in the preparation of environmental monitoring data trending reports.
- Monitor temperatures of Manufacturing and Microbiological QC refrigerators, freezers, cryo-freezers, and cold-room area.
- Other tasks as assigned.
Benefits
- health, dental, and vision insurance
- 401(k) matching
- paid time off
- opportunities for career growth and development
- supportive and inclusive work environment
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
