QC Microbiology, Analyst I
South San Francisco, CA 94080 US
Job Description
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
- Bachelors 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.
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