Microbiologist

Employer
Aerotek
Location
Agoura Hills, California, US
Salary
Competitive
Posted
Jun 06, 2021
Closes
Jun 24, 2021
Ref
2238947059
Discipline
Other
Employment Type
Full time
Salary Type
Salary
Description:
Setting up and creating SOPs for Sterility testing for Clinical manufacturing
Quality Control Microbiologist I
You will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products. This role will be a hands-on resource reporting to the QC Manager.
Responsibilities (include, but are not limited to):
• Coordinate daily scheduling of tests and activities including, but not limited to, EM, Gram stain, growth promotion, and sterility
• Inventory management
• Counting, recording, and reporting colonies and growth from EM, AOQ, and APS plates and samples
• Collaborate with sample management on sending required samples out to contract testing laboratories or other recipients
• Performing, managing, and enhancing the sterility testing of final drug product in accordance with compendial methods
• Participate in execution of protocols, method validations, and other assay developments
• Establish user requirements for purchase of new equipment
• Collaborate with QC Analytical management in establishing product specifications
• Participate in environmental investigations
• Enhance and/or develop laboratory methods when needed
• Complete routine record and test data review
• Metrics:
o 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
o Assemble and report contract laboratory testing data
• Other duties as assigned
Requirements:
• Associates/Bachelors in Biology, Microbiology, or other life science based equivalent
• Minimum 2 years' experience working in a QCM laboratory or similar GMP setting
• Ability to successfully pass a gowning certification program and perform duties under aseptic gowning requirements
• Comfortable instructing others in aseptic technique and EM operations
• Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
• Good interpersonal, verbal, and written communication skills
• 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
• Working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological testing, and auditing.
• Identifying, authoring, and supporting OOS and DRs
• Equipment IQ/OQ/PQ knowledge
• Comfortable in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
Quality Control Microbiologist II
You will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products. This role will be a hands-on resource reporting to the QC Manager.
Responsibilities (include, but are not limited to):
• Coordinate daily scheduling of tests and activities including, but not limited to, EM, Gram stain, growth promotion, and sterility
• Inventory management
• Counting, recording, and reporting colonies and growth from EM, AOQ, and APS plates and samples
• Collaborate with sample management on sending required samples out to contract testing laboratories or other recipients
• Performing, managing, and enhancing the sterility testing of final drug product in accordance with compendial methods
• Participate in execution of protocols, method validations, and other assay developments
• Establish user requirements for purchase of new equipment
• Collaborate with QC Analytical management in establishing product specifications
• Participate in, or lead, environmental investigations including deviation write-up
• Enhance and/or develop laboratory methods when needed
• Complete routine record and test data review
• Perform trainings on best aseptic technique, CAPA requirements, best gowning practices, and other trainings as assigned
• Metrics:
o 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
o Assemble and report contract laboratory testing data
• Other duties as assigned
Requirements:
• Associates/Bachelors in Biology, Microbiology, or other life science based equivalent
• Minimum 2 - 3 years' experience working in a QCM laboratory or similar GMP setting
• Ability to successfully pass a gowning certification program and perform duties under aseptic gowning requirements
• Comfortable instructing others in aseptic technique and EM operations
• Proficient in MS Office products including, Word, Excel, Outlook, and Power Point
• Good interpersonal, verbal, and written communication skills
• 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
• Working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
• Must have working knowledge of controlled documentation, data systems, cGMPs, SOPs, microbiological testing, and auditing.
• Identifying, authoring, and supporting OOS and DRs
• Equipment IQ/OQ/PQ knowledge
• Comfortable in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
Skills:
environmental monitoring, Microbiology, Laboratory, iso5, cGMP, Quality control, Biomerieux, BacT Alert, sterility testing, endotoxin, sterility, qc-micro
Top Skills Details:
environmental monitoring,Microbiology,Laboratory
Additional Skills & Qualifications:
Must have solid Micro and EM Experience from a regulated environment
Experience Level:
Expert Level
About Aerotek:
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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