Quality Supervisor

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.
The Laboratory Quality Assurance Supervisor performs quality assurance activities of the BioLife Testing laboratory by performing the following duties personally or through subordinates. Ensures laboratory compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety. Responsible for supervising a team of quality assurance coordinators to oversee the review of testing records, instruments records and quality control records to ensure that quality assurance standards and regulatory requirements are met prior to release of results from the PCR Pooling Laboratory, Serology Testing Laboratory and Anti-D Laboratory. This includes responsibility for 1st and 2nd shift quality coordinators which may require, at times, work on both shifts. Ensures that team of quality assurance coordinators are trained and certified prior to performance of duties as well as maintain competency for duties performed. 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. Ensures that Quality Assurance Review SOPs are current and accurate. Immediately communicates significant concerns identified to the laboratory Quality Assurance Manager to ensure that questionable test results are not released. May stop operations when product safety is or may be compromised. May require occasional travel. Other duties as assigned.Qualifications
Technical Bachelor's degree from an accredited college/university required. Technical/Professional certification preferred. Familiarity with quality assurance and regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment. Prior experience with auditing and/or inspection processes preferred. Minimum two years experience in a professional or technical capacity in blood services or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity preferred.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
REQUIREMENTS
Please see Job Description