QC Microbiology, Analyst I

San Francisco, CA 94080

Posted: 05/22/2023 Job Number: 37452

Job Description


Pay range is $22 - 27 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

 

QC Microbiology, Analyst I


Purpose & Scope:
  • The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials, and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines.

Essential Job Responsibilities:
  • Support Quality Control testing of drug substances, raw materials, and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines
  • Perform bioburden, endotoxin, pH/Conductivity, and other tests as needed
  • Perform viable air, non-viable particulate, surface/swab environmental monitoring (EM) of manufacturing areas
  • Perform sampling and testing for gas, utilities, and purified water
  • Perform growth promotion/media sterility check, Gram staining and microbial cryopreservation
  • Perform plate reading, generate microbial isolates, and shipping of isolates for identification
  • Receive, unpack, and organize supplies for QC areas
  • Revise SOPs, Forms, and approved documents
  • Initiate deviation and OOS investigations, as encountered
  • Support Fill and Finish operations
  • Assist in data trending and summarization
  • Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP requirements
  • Assist in performing laboratory Investigations

Quantitative Dimensions:
  • Support Quality Control Microbiological testing of drug substances, raw materials, and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines.

Organizational Context:
  • New position for the QC Microbiology Department
  • Reports to the QC Microbiology Supervisor

Qualifications:

Required:
  • Bachelor’s Degree in chemistry, biology, or microbiology with 0-3+ years’ relevant microbiology laboratory experience in Pharmaceutical/Biotech.
  • Excellent knowledge of Aseptic technique and common microbiological testing
  • Knowledge of relevant, compliance and guidance documents
  • Must be able to gown into cleanrooms in support of testing and manufacturing activities
  • Good documentation (ALCOA +) and data organization
  • Detail oriented and willingness to learn and follow instructions
  • Interpersonal skills and ability to contribute to the success of a team

Preferred:
  • Proven history of working in a fast-paced team environment, time management, and meet deadlines.
  • Team player with the ability and willingness to support other colleagues in the Quality Control department. This support may include future cross training with analytical assays as needed
  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Working Conditions:
  • Must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required
  • Must be proficient in use of computer, particularly Microsoft Word and Excel programs, and be able to sit/stand and be gowned inside the cleanroom for extended periods of time. Some lifting required (not more than 50 lbs.). Routinely able to stand, walk, kneel, and crouch while performing sampling, such as environmental monitoring.
  • Ability to tolerate the smell of Gram-negative organisms and disinfectants (i.e. 1% bleach, SporeKlenz) may be needed. Use of a respirator may be required. Exposure to biohazards and viruses.

Meet Your Recruiter

Scott Brasel

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.