Company: CAPS Micro Irvine Facility
Posted on: January 23, 2023
OverviewCAPS -, the nation's largest network of outsourcing
admixture pharmacies, has been delivering high-quality, same-day,
admixture services and solutions to hospitals and outpatient
facilities for more than 28 years. Along with the nation's largest
503A sterile injectable outsourcing network, CAPS offers
industry-leading batch compounding on a national scale through
three 503B registered outsourcing facilities. With experience,
capacity, and a passion for safety, CAPS is your 503B solution.CAPS
is part of the B. Braun Group of Companies in the U.S.
ResponsibilitiesPosition Summary: Responsibilities: Essential
- Plans, coordinates and organizes the overall activities of the
Microbiological Laboratory according to internal and external
standards in a most cost effective way.
- Directly responsible for the supervision test operation at all
time for Sterility Testing, Bacterial Endotoxin Test,
Microbiological Identification Sections and handling of laboratory
- Ensures that the necessary microbiological tests are done
according to the test specification, test method and working
instruction and to ensure release on time for pharmaceutical
products and medical devices.
- Responsible for the preparation and updating of the GMP/ISO
procedures in the area of responsibility.
- Participates in projects, task force jointly with production
personnel in case the needs arise.
- Prepares trend analysis and data compilation on deviation in
the production process when required.
- Participates in internal and external audit.
- Participates in the Global Microbiology Task Team, whenever
- Responsible in microbiological release of medical devices or
Pharma products and Pharma incoming materials.
- Supports microbiological tasks for process validation.
- Trains and proactively develops the education standard of the
responsible persons. The job function listed is not exhaustive and
shall also include any responsibilities as assigned by the
Supervisor from time to time. Expertise: Knowledge & Skills
- Requires basic knowledge of relevant business practices and
procedures in professional field. Uses standard theories,
principles and concepts and integrates them to propose a course of
- Works under general supervision. Relies on experience and
judgement to plan and accomplish assigned goals. May periodically
assist in orienting, training, assigning & checking the work of
- Some degree of judgment required in resolving problems based on
- Contacts are primarily with direct supervisor, peers and
subordinates. QualificationsExpertise: Qualifications
- Bachelor's degree required.
- 0-02 years related experience required.
- Regular and predictable attendance
- Ability to work non-standard schedule as needed While
performing the duties of this job, the employee is regularly
required to sit and talk or hear. The employee frequently is
required to use hands to handle or feel and reach with hands and
arms. The employee is occasionally required to stand and walk. The
employee must occasionally lift and/or move up to 20 pounds. .
Keywords: CAPS Micro Irvine Facility, Irvine , Microbiologist I, Other , Irvine, California
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