Quality Mgmt. Representative

Job Category: Quality Assurance/Safety Company: Baxter Healthcare Reference Code: 33025BR Quality Mgmt. 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. Stays current with federal, state, local and company-specific rules, regulations and practices. Ensures 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 include all 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 center management and Regional Quality Management Representative. May stop operations or shipments when donor or product safety is or may be compromised. Works in collaboration with Facility Manager and management team to prepare for and host (if needed) internal and external auditors. Assists center management teams to ensure timely closure of audit observations. 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 plasma collection, sample collection, plasma storage, product release, quality assurance, tetanus immunizations and employee training and competency assessment. Initiates SOP revisions as needed to support continuous improvement. Ensures that SOPs are current and validated and that staff perform routine tasks according to SOP through direct observation. Ensures that required validation protocols are performed and reported according to established guidelines. Coordinates management review meetings and participates in center staff meetings. Other duties and responsibilities as assigned. May be responsible to support and conduct QMR training, in addition to other projects as assigned by Regional Quality Management Representative. QUALIFICATIONS: Computer skills in word processing, spreadsheets, and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem solving skills. Associate degree in a scientific discipline and one to three years of plasma center experience within most recent 5 years or an equivalent combination of education and experience. Bachelors degree in the life sciences, business or other technical field preferred. Physical Demands/Work Environment Office/Production environment. May require weekend and extended work periods. May assist in center operations, as needed which requires bending, stooping and lifting up to 50 pounds. Potential exposure to blood-borne pathogens. 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.