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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Coordinate all activities required to occur for assigned shift responsibilities relative to the QC Particulate Matter (PM) Laboratory
Personnel management
Conducting non-conformance investigations within TrackWise 8 for procedural non-compliances and non-conforming results
Assign tasks, set priorities, and ensure effective performance and development of team members
Conduct regular training for staff
Conduct ACE Check-ins with staff and additional communications as needed
Ensure USP <1790> and USP <788> testing is performed accurately and efficiently, following established protocols and standards
Oversee the accurate recording and analysis of test results, review results, and address documentation errors in accordance with procedural requirements
Ensure results are provided to document control within specified timeframes for release
Cross train in all areas of the QC Microbiology Laboratory which has staffing represented on night shift to enable troubleshooting of issues and/or guidance as necessary
Perform documentation review of all areas of QC Microbiology Laboratory as assigned by the Quality Manager
Troubleshoot and resolve any issues that arise during testing or lab equipment
Conduct Phase 1 Laboratory investigations within TrackWise 8 for QC PM Lab, and facilitate elements of Phase 1 Laboratory investigations for other areas of the laboratory as needed
Ensure that all data is documented properly, and reports are generated and reviewed in a timely manner
Implement and enforce safety protocols and practices within the laboratory
Requirements:
B.S. Degree in Life Science Field (e.g. Biology, Microbiology, related)
Minimum of 5 years of experience or Master’s Degree in biological science with applied experience, preferably in the pharmaceutical or medical device industry
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs, and USP testing methodology
Computer skills including knowledge of Microsoft office applications (Word, Excel)
Able to manage multiple tasks/priorities in a timely manner
Able to work independently and manage time to complete assigned tasks
Ability to create an environment that values people, encourages trust, and open communication through feedback and recognition
What we offer:
Shift flexibility to trade shifts and leverage overtime opportunities