Microbiologist *PC in San Jose, California

Job Title

This position is primarily responsible for performing environmental and process related monitoring at various stages of the production process. Also responsible to initiate deviations and Out Of Specification's (OOS's) associated with microbiological testing while participating in process and laboratory improvements such as development of procedures and studies.

Essential Duties and Responsibilities:

• Perform environmental and process related monitoring at various stages of the production process Initiates deviations and Out Of Specification's (OOS's) associated with microbiological testing.
• Support Inventory Management, filing and record keeping Ensures all equipment is properly maintained/calibrated
• Perform, manage, and enhance the sterility testing of final drug product in accordance with compendia! methods.
• Participate in process and laboratory improvements, such as development of procedures and studies (i.e. Ss, Kaizen, Six Sigma) and execution of protocols, method validations, and other assay developments.
• Support the QC Microbiology laboratory with regards to enumerating and trending of EM samples, raw material testing support, coordination of samples to send out, etc...
• Collaborate with Sample Management on sending required samples out to contract testing laboratories or other recipients
• Collaborate with QC Analytical Management in establishing product specifications. Establish user requirements for purchase of new Miltenyi GMP equipment Assemble and reports contract laboratory testing data.
• Perform data entry for tracking & trending of lab reports.
• Count, record, and report colonies and growth from EM, AOQ, and APS plates and samples. Complete routine record and test data review.
• Coordinate daily scheduling of tests and activities including, but not limited to, EM, Gram stain, growth promotion, and sterility.
• Participate in environmental investigations.
• Support team with enhancements and/or developments for laboratory methods, when needed.
• Assemble and report quarterly, annual, and customized trend reports for environmental monitoring, personnel monitoring, excursions, and out of trend data in support of continuous improvement.
• Other duties as assigned.

Requirements:

• Bachelor's degree in biology, Microbiology, or other life sciences; 5+ years of experience working in a QCM laboratory or similar GMP setting.
• Domestic Travel Requirements- 10% or less

Knowledge/Skills/Abilities:

• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological testing, and auditing.
• Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
• Strong technical knowledge in various microbiological techniques including rapid release methods, environment qualifications, and cellular therapy-based products.
• Experience in the application of microbiological techniques such as air monitoring, surface monitoring, and genus and species identifications.
• Working knowledge of quality systems and regulatory requirements (including 21 CFR Part 11/210/211) Experience identifying, authoring, and supporting OOS and DRs
• Experience in a fast-paced environment with minimal direction and ability to adjust to a dynamic work environment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers.

While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $47.29 - $55.63/year, reflecting the range candidates can reasonably expect to be…