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Quality Management Rep
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
- 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.
- 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.
- Ensures that SOPs are current and validated and that staff perform routine tasks according to SOP through direct observation. Initiates updates as necessary.
- Demonstrated understanding of quality assurance in an FDA-regulated environment.
- 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.
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
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