Pharma Product Release Supv.
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.
1) Plans and schedules the work of Quality Associates.2) Ensures that all batch record documentation are properly completed and reviewed and released. This includes on the floor review of batch records.3) Tracks product releases through Release tracking system and attends daily fulfillment meetings to meet customer requirements.4) Works with production supervision, planning and laboratories to coordinate the release to internal and external product customers.5) Communicates daily with internal intermediate and final container product customers to assure release timelines are communicated and met.6) Develops and maintains all QM Release procedures, forms, checklists and Certificates of Analysis. Ensures product compliance regulations are followed.7) Hires, trains and evaluates all personnel through the PMO and Development systems. Makes wage and salary recommendations and maintains performance records. Supervise staff working on various shifts.8) Responsible for preparing budget and oversight to assure budget requirements are met.Qualifications
1) Working knowledge of PC based systems including, Access, Word, JD Edwards One World interface, Pillar (budget system), LIMs and lotus notes.2) Strong communication skills are needed to effectively supervise support personnel.3) Good time management, project management skills to assure timely release of product.4) Bachelor's degree in Science, Engineering, or related field with 3-5 years of Quality experience.5) Requires scientific and technical knowledge in the areas of manufacturing, laboratory testing, documentation and regulations.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
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