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Quality - Testing Lab Associate
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.A division of Baxter Healthcare Corporation,
BioLife Plasma Services is an industry leader in the collection of high-quality
plasma that is processed for life-saving plasma-based therapies used in the
management of hemophilia, immune deficiency disorders and for blood volume
replacement in trauma situations.
BioLife operates and maintains more than 55 state-of-the-art plasma
collection facilities in more than 20 states across the United States. Our premier Testing Laboratory is located in Hoover, AL. - Ensures laboratory compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
- Reviews and approves final release of laboratory data from the laboratory to PCR DMS.
- Works with laboratory management team to prepare for and host internal and external auditors. Assists laboratory management team to ensure timely closure of audit observations.
- Reviews and tracks nonconformances and quality control data as required by laboratory quality assurance procedures. Immediately communicates significant concerns identified to the laboratory Quality Assurance Manager or Quality Assurance Supervisor to ensure that questionable test results are not released. May stop operations when product safety is or may be compromised.
- Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to cGMP requirements to ensure that quality assurance standards and regulatory requirements are met prior to release from the Quality Assurance Department.
- Maintains current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
- Performs revisions to Standard Operating Procedures as assigned.
- Assist in training staff in certified areas of review.
- Demonstrated understanding of quality assurance in an FDA-regulated environment.
- Demonstrated understanding of plasma center operations is preferred.
- Bachelors degree in the life sciences, business or other technical field .
- 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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