Job description
QC Microbiology Technician - Warminster, PAJob Description
The overall objective of the QC Microbiology Technician for is to perform quality control testing on microbiological culture media. The successful candidate will have responsibility for testing and releasing raw materials, intermediate products, and finished goods. This role will also be responsible for carrying out equipment calibration and verification in the QC lab and production environment. Responsibilities for this role include:
- Perform routine testing of raw materials, intermediate products, and finished goods to ensure that products are meeting specifications. Testing includes, but is not limited to, pH, sterility, and growth promotion.
- Maintain optimal inventory of QC lab supplies and organisms
- Perform equipment calibration or verification as scheduled, or assist in scheduling third-party service contractors to perform calibration.
- Review production worksheets and QC data to ensure all product and process specifications are met
- Document non-conformances and deviations
- Perform testing to troubleshoot non-conforming product
- Perform in-process inspections and investigations in support of manufacturing, perform environmental monitoring as required
- Create lot-specific Certificates of Analysis based on QC test results
- Carry out new product testing as part of design and development and technology transfer of new products
- Perform stability testing/ shelf life studies
- Adhere to all organizational SOPs
- Assist Quality Manager in implementation of the Quality Management System, including assisting in performing internal audits and helping with third-party audits
- Perform other duties as assigned
The ideal candidate should have a Bachelors degree in Microbiology or a related discipline and 1-3 years of microbiology laboratory experience.
In addition:
- An understanding of ISO 9001 and ISO 13485 is preferred
- Work independently with minimal supervision, exercising good judgement
- Ability to work sitting or standing for long periods of time
- Able to wear appropriate personal protective equipment
- Able to work occasional evenings or weekends as required
- Authorization to work in the United States indefinitely without restriction or sponsorship
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