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Quality Assurance Specialist
2 months ago
As a Quality Assurance Specialist focusing on GMP compliance, you will play a critical role in ensuring the integrity of our water systems and raw materials. Your expertise will be essential in maintaining the highest standards of quality and safety in our operations.
Key Responsibilities
- Water Systems: Conduct GMP evaluations of microbiological assessments for facility and laboratory water purification system samples, including tests such as LAL and Bioburden.
- Analytical Testing: Perform GMP reviews of analytical tests on water purification system samples, including TOC, Conductivity, and EU WFI Chemical Testing.
- Qualification and Media Release: Oversee GMP reviews related to Qualification and Media Release testing.
- Facility Cleaning Data: Review cleaning data and in-process testing, focusing on parameters such as endotoxin, bioburden, HPLC, protein concentration, pH, and osmolality.
- Alert Management: Initiate and monitor exceeded alert and action limits in accordance with established procedures.
- Quarterly Reporting: Contribute to the preparation of quarterly trending reports.
- Raw Materials: Evaluate general appearance and identifications, including FTIR analysis, and manage house gas/air sampling and testing.
- Sample Management: Handle the electronic and physical receipt, logging, and distribution of samples and testing materials entering QC.
- Sample Custody: Ensure proper discarding and completion of the sample custody chain.
- Preparation and Shipping: Prepare and ship samples/materials, including aliquoting bulk samples and assay standards.
- Laboratory Support: Assist in the development and revision of SOPs, and perform routine calibration and maintenance of laboratory equipment.
- Cleaning Duties: Maintain cleanliness of incubators, laminar flow hoods, biosafety cabinets, refrigerators, cold rooms, and freezers.
- Investigations: Participate in investigations related to equipment out-of-tolerance (OOT) and support documentation review and maintenance.
Qualifications:
We are looking for a detail-oriented professional with a strong background in quality assurance and GMP practices. Your contributions will be vital in upholding our commitment to quality and compliance.