Sr Microbiologist
Company: ProStaff Solutions
Location: Billerica
Posted on: June 20, 2022
Job Description:
Direct Hire
Job Summary:Oversee day to day operations of the QC Microbiology
Laboratory. Ensure that required microbiology activities related to
supporting manufacturing of aseptically processed pharmaceuticals
are performed in compliance with company policies and procedures
and regulatory guidance.
- Responsibilities:Assure that microbiology testing for raw
materials and finished product is completed to meet product
manufacturing requirements for manufacture and release, including
oversight of receipt of samples, testing, review and reporting of
results
- Schedule and coordinate product Sterility, Endotoxin and
bioburden testing
- Perform and or oversee endotoxin, sterility and bioburden
method validations as well as other non-product related validations
related to product testing and transfer. This includes authoring,
executing and completing protocols as required
- Coordinate the microbial identification program related to
environmental and utility monitoring
- Coordinate validations of equipment and instruments supporting
Microbiology Laboratory Operations
- Coordinate outsourced laboratory testing for raw materials and
product
- Provide training for employees on functions related to QC
Microbiology such as Sterility, Endotoxin, and Bioburden
Testing
- Assure that laboratory procedures are current and update
applicable procedures as required
- Assure that all activities are documented, executed and in
compliance with current Good Manufacturing Practices (cGMPs), Good
Laboratory Practices (GLP), Good Documentation Practices and
company policies
- Other duties as assigned
Qualifications:
- BS in Microbiology
- Minimum 6-8 years related experience in a Pharmaceutical/drug
(FDA Regulated) industry preferred
- Experience with sterility testing, endotoxin assays and
validation, microbiological limits testing, knowledge of USP and
EP/BP method/validation regulations, Microbiological identification
method
- Work under minimal supervision using Standard Operating
Procedures and good judgment to effectively coordinate and execute
assigned activities in support of production, Quality Control and
Research & Development activities
- Knowledge of cGMP and GLP, FDA/USP require Experience in a
clean room environment required
- Strong verbal, written and interpersonal communication with an
emphasis on creating a motivated, effective working team
- Strong organizational skills, the ability to prioritize work
and manage multiple tasks independently
- Demonstrated experience conducting investigations, writing
protocols, SOP's, validating methods, staff training,
- Strong computer skills and proficient at word processing and
utilizing spreadsheets
- Strong industry experience in pharmacopoeia testing,
sterilization validation and general pharmaceutical
microbiology
- Knowledge of microbiology (industrial), environmental, and
utility monitoring and aseptic processing
Keywords: ProStaff Solutions, Billerica , Sr Microbiologist, Other , Billerica, Massachusetts
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