Quality Management Representative

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
This position is located in Kokomo, IN.

The Quality Management Representative (QMR) is responsible for helping to support and manage the quality function of a plasma collection facility. This includes ensuring center compliance with all federal, state, local and company specific regulations related to quality of
product, employee, and donor safety. Reviews records to ensure they are complete, accurate and
compliant with cGMP requirements. Records operational documents (donor history and medical cards, equipment calibration and
maintenance, employee training, laboratory test results, packaging,
inventory, shipment, etc.)
involved in the processing and shipment of plasma as it relates to donor, employee and product safety. Tracks deviations in
operating procedures and policies through established mechanisms. Reports errors, deficiencies,
discrepancies and observations to Operations Management and Regional QMR. Works in collaboration with Operations Manager and management team to prepare for and host (if needed) internal and external auditors. Tracks responses to and corrective action for exception
variances, error and accident reports, and post-donation information reports. Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source and sample plasma collection, plasma storage, product release, quality assurance, tetanus immunizations and employee training and competency assessment. Ensures SOPs
are current and validated and staff performs routine tasks according to SOP through direct observation. Revise SOPs as needed. May be responsible to support and conduct QMR training, in addition to other projects, duties and responsibilities as assigned.

Qualifications
Associate degree in a scientific discipline and one to three years of plasma center experience or an equivalent combination of education and experience. Bachelors degree in the life sciences, business or other technical field preferred. Computer skills in word processing,
spreadsheets, and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment and understanding of plasma center operations. Effective
organizational, technical and problem solving skills.

As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V