Career Category

Job Description

The Quality Control (QC) Manager position will supervise a team responsible for QC Equipment Management at Amgen Rhode Island and will contribute to fostering and further developing the culture of Safety, Quality, and Lean Leadership.

The QC Manager will contribute directly and provide oversight to a team responsible for the following functions in support of core QC laboratory operations:

• End to end life cycle for QC equipment, including the procurement, development and execution of validation and change control strategy/ownership, oversight of general and preventive maintenance activities, and decommissioning as required.
• Site SME/Representative on QC System Owner Network (fields requests/provides advice to other sites, alignment decisions with other sites)
• Document ownership of Master List QC Equipment, QC and Manufacturing Computerized Analytical Lab Systems List
• Quality review Data Integrity Assessments for computerized systems and Function Tests done by Automation (alarm changes, graphic changes, and parameters)
• Comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls

Basic Qualifications:

• Doctorate degree
• OR
• Master’s degree and 3 years of Quality or Equipment Management experience
• OR
• Bachelor’s degree and 5 years of Quality or Equipment Management experience
• OR
• Associate’s degree and 10 years of Quality or Equipment Management experience
• OR
• High school diploma / GED and 12 years of Quality or Equipment Management experience

Preferred Qualifications:

• Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
• Experience with equipment procurement, development and execution of validation, general and preventive maintenance activities
• Excellent interpersonal, written and verbal communication skills with all levels within the organization
• Ability to work in a team matrix environment and build relationships with partners
• Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions
• Experience with supporting staff training, career development and performance management
• Establishment and tracking of department goals, strategies and KPIs
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections
• Experience with various laboratory equipment and computer systems
• Strong leadership and negotiation skills with a demonstrated ability to influence different styles
• Demonstrated innovative thinking and ability to transform work organizations
• Exposure to Operational Excellence initiatives
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule

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