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.Quality Line Operations - Quality Associate I - 3rd Shift
- Stays current with federal, state, local and company-specific rules, regulations and practices.
- Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
- Reviews records to ensure they are complete, accurate and compliant with cGMP requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
- Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
- Works in collaboration with management team to prepare for internal and external auditors. Assists with timely closure of audit observations.
- Authors Exception Reports, Risk Assessments, and corrective action responses for exception variances.
- Conducts monthly/quarterly quality assurance audits for critical logbooks and bi-annual inspections of classified areas.
- Initiates SOP revisions as needed to support continuous improvement.
- Ensures that SOPs are current and effective and that staff perform routine tasks according to SOP through direct observation.
- Other duties and responsibilities as assigned.
- Computer skills in word processing, spreadsheets, and databases highly desirable.
- Demonstrated understanding of quality assurance in an FDA-regulated environment.
- Demonstrated understanding of aseptic processing operations.
- Effective organizational, technical and problem solving skills.
- Bachelors degree a Science related field.
- Physical Demands/Work Environment Office/Production environment.
- May require weekend and extended work periods.
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.
