Quality Control Supervisor - Calibration

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The Position

We advance science so that we all have more time with the people we love. As the Quality Control Supervisor – Calibration, you will lead the activities of quality control systems.  You will be responsible for daily operational implementation of standards, methods and procedures for maintaining the instrument management system, executing the calibration of instruments, and liaising with vendors which provide calibration services.  You will make recommendations for corrective action necessary to ensure conformity with quality standards.  You will also ensure the calibration of instrumentation conform to government and company standards and satisfy good manufacturing practices regulations.  You will select, develop and evaluate personnel to ensure the efficient operation of the function.

You will devote a significant amount of time to leading and managing employees.  You will oversee the day-to-day operations for assigned work group or team. You will provide feedback to the manager on employees' work performance and have input into employment decisions.  Occasionally, you may do the work of those supervised.  You will also be responsible for managing to a prescribed budget, training and development of staff, resource management, work assignments, interpret and ensure consistent application of organizational policies.

You will ensure the RDCI Quality Policy is understood, implemented and maintained in the organization. You will establish and maintain an adequate organizational structure, provide adequate resources and establish appropriate management controls to ensure their group is suitable and effective to satisfy regulatory requirements and the company’s quality policy and objectives. You will also perform the quality planning to drive continuous improvements and changes of the RDCI quality system to ensure ongoing effectiveness and efficiency. You will develop and drive a work culture committed to compliance, quality and customer focus.

The Opportunity:

1. Manages the Calibration department for Internal Manufacturing Indianapolis. Responsible for the identification, purchase, and administration of appropriate service contracts and calibration vendors.

2. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. Develops and revises calibration Standard Operating Procedures (SOPs).Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations. 

3. Leads effective execution of all people management tasks and responsibilities consistent with company policies, processes and procedures. 

4. Evaluates instrumentation specifications and design applications to identify potential issues that could result in operational vulnerabilities affecting regulatory compliance, excessive costs, reliability, and reduced system availability.

5. Creates and revises preventive maintenance, operational and calibration procedures for instruments throughout the facility.

6. Develops budget and monitors expenditures. 

7. Ensures skills of personnel are current and that developmental needs are identified and met. 

Coordinates staffing, training, scheduling and capacity planning requirements with assistance from area management. 

8. Set an example as a VACC leader, including promoting a creative mindset.

9. Enable the organization’s New Ways of Working and support access to the right resources.

10. Act as role model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in the Roche Operating Principles.

Who You Are:

• Bachelor’s degree in Engineering, Science or related field.

• 3+ years of experience or equivalent work experience.

• Ability to lead and motivate team members, solve problems and create cohesive team work.

• Ability to manage multiple tasks simultaneously.

• Excellent oral and written communication skills.

• Proficiency with MS Word, Excel, and PowerPoint and analytical tools.

• Ability to take goals/vision to drive success

Preferred:

• Previous experience within FDA regulated industry.

• Previous experience in manufacturing operations or manufacturing