Job Description Summary

Directly supervises the efforts of the sterilization testing group within the Quality Laboratory. This includes managing projects related to process development and improvements. Ensure medical devices tested meet specifications in support of manufacturing. Direct day to day activities and set team priorities.

Job Description

RESPONSIBILITIES

• Directs the workload of the sterilization group within the Quality Laboratory and determines priorities to meet site goals.
• Ensures that product is tested in a timely manner, minimizing any impacts to production scheduling and release of finished product.
• Determine residual testing requirements and perform risk analysis for process failures.
• Perform gap assessments of local documents with corporate and regulatory guidelines to maintain compliance.
• Authors, reviews, and updates standard operating procedures.
• Investigates OOS/OOT or aberrant laboratory results and determines corrective actions.
• Supports project teams that require lab and sterilization involvement.
• Write and approve protocols, reports, and analyze data using statistical methods.
• Effectively communicates test results to other areas in the plant and other BD sites.
• Maintains metrics at the site and corporate level to promote continuous improvement.
• Manage direct reports, including hiring, mentoring, performance reviews and disciplinary actions.
• Coordinates validation and equipment maintenance with lab system administrator.
• Support the quality department by participating in internal and supplier audits.
• Ensures testing and documentation is performed according to GMP practices.
• Ensures good housekeeping practices are followed in the area.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as assigned.

Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift