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Sr. Microbiologist, Quality ControlAvid Bioservices • Tustin, California, United States
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XX

Sr. Microbiologist, Quality Control

Avid Bioservices
  • US
    Tustin, California, United States
  • US
    Tustin, California, United States
Ähnliche Jobs finden

Über

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.
  • 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.
Minimum Qualifications:
  • 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.
Position Type/Expected Hours of Work:   This role is a full-time position with a Sunday through Wednesday schedule, working 10 hours each day (4 days x 10 hours), with operating hours typically from 7:00am to 6:00pm.  Compensation:    We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.     The compensation range for this role is $65,800 to $75,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.   Who you are:
  • You have a "bring it on" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:    In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.  
  • Tustin, California, United States

Sprachkenntnisse

  • English
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