Microbiologist PC 609

Miltenyi Biotec•San Jose, CA

13d•Onsite

About The Position

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 OOS's associated with microbiological testing while participating in process and laboratory improvements such as development of procedures and studies. The role supports the QC Microbiology laboratory with regards to enumerating and trending of EM samples, raw material testing support, and coordination of samples to send out. It also involves collaborating with Sample Management on sending required samples out to contract testing laboratories and with QC Analytical Management in establishing product specifications. The position establishes user requirements for purchase of new Miltenyi GMP equipment and assembles and reports contract laboratory testing data. Data entry for tracking & trending of lab reports, counting, recording, and reporting colonies and growth from EM, AOQ, and APS plates and samples, and completing routine record and test data review are also key functions. The role coordinates daily scheduling of tests and activities including EM, Gram stain, growth promotion, and sterility, and participates in environmental investigations. Support is provided to the team with enhancements and/or developments for laboratory methods, when needed. The position also assembles and reports 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
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.

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.
Establishes 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.