To oversee the management of the techniques and personnel required for all Quality Control testing. The position requires supervision in a regulated environment with strict adherence to procedures and attention to compliance.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
Ensures completion of all testing including special projects/protocol testing and establishes priority of the workload. Reviews testing documentation and LIMS entries for the validity and accuracy of test execution and results
Upholds policies and procedures by ensuring compliance with internal quality guidelines and regulatory agency at all times.
Defines equipment and facility repairs and maintenance and assures calibrations or service contracts are completed on schedule. Assesses need for new or additional equipment and completes current capital requests and other documentation for proper functioning of the lab as a unit.
Assist in personnel management including staffing recommendations and works with HR for recruiting, hiring and training, disciplinary/corrective actions, coaching, and terminations. Completes evaluation of personnel performance via performance appraisals and ensures development plans are in place. Monitors attendance of staff for payroll purposes, including overtime, vacation and leaves of absence
Leads or participates in functions involving teams within QC or other areas, which impact production, increase efficiency, solve problems, generate cost savings, or improve quality.
Monitors and develops key performance indicators and takes appropriate actions to maintain favorable outcomes
Acts as a subject matter expert for Quality Control techniques. Reviews documentation for accuracy and compliance, including Special Outlines and Outlines of Production
Requirements
Bachelor’s Degree from an accredited institution in Science or related field
Minimum of seven (7) years of laboratory experience
Bound to regulatory and safe environment.
Knowledge of a regulatory environment, understanding of production processes
Knowledge of GMP and 9CFR regulations
Good English written and verbal communication skills
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