Join Grifols, a global healthcare company, as a Microbiology Principal Scientist. Ensure product tests are validated in a timely and GMP-compliant manner, develop new biochemical and microbiological methods, and supervise execution of protocols.
Requirements
- Develops new biochemical and microbiological methods for testing Grifols products and process samples
- Designs protocols for validating existing and new test methods and supervises execution of these protocols
- Assists in the transfer of validated methods to the Grifols QC laboratory
- Assists in developing and maintaining a schedule for the validation of QC tests for process intermediates and final product
- Designs protocols for installation, operation and performance qualifications of new QC analytical instruments and maintains the schedule for completing these qualifications
- Identifies resources, equipment and supplies that are required to perform validation of process intermediate and final product tests
- Maintains system for timely purchase and qualification of laboratory equipment and reagents
- Reviews and revises standard operating procedures for technical accuracy and compliance with regulatory requirements
- Assists the QC department in troubleshooting or investigating instrument and assay problems
- Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement
- Maintain current knowledge of regulatory and industry standards
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility
- Strict adherence to procedures and practices according to FDA regulations
- Strong emphasis on documentation according to FDA regulations
- Adhere to departmental corporate safety policies
Benefits
- Medical, Dental, Vision
- PTO
- up to 5% 401(K) match
- Tuition reimbursement
