Lead Specialist QA Operations (1st Shift)

About the role

This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. As the Lead Specialist QA Operations (1st Shift), you will make an impact by ensuring quality standards and regulatory compliance in a global healthcare company that supplies high-quality medicines to approximately 1 billion patients annually.

Responsibilities

• Directly participate in the training and development of QA Specialists, Senior Specialists, and Supervisors in QA Operations functions and GMP regulations.
• Provide leadership and daily oversight of Quality Assurance Specialists, as directed by management.
• Lead and participate in quality improvement team activities and cross-functional teams, providing QA input.
• Assist management with strategic planning of intermediate batch record review/release, finished product batch record review, and other QA Specialist floor operations.
• Oversee QA Specialists’ evaluation and triage of events, deviations, and unplanned maintenance activities.
• Oversee the On-Hold material program, mentoring QA Specialists/Supervisors in monitoring and disposition of material.
• Perform QA review/approval of controlled documents, written procedures, protocols, and MES recipes, as required.
• Prepare and provide information for inclusion in monthly quality metric reports.
• Assure deviations are appropriately reported and participate in investigations of deviations, as required.
• Support review and approval of Trackwise® incidents related to manufacturing operations.
• Identify and implement continuous improvements for the elements of the quality system related to manufacturing operations.

Requirements

• Bachelor’s degree.
• 10+ years of relevant experience in a GMP environment.
• Comprehensive knowledge of Quality Systems and cGMP.
• Effective written and oral communication and interpersonal skills.
• Ability to constructively work across functional areas to achieve results.
• Ability to multi-task a number of projects and evaluate priorities with minimal supervision.
• Maintain working relationships with individuals within Mylan Technologies and Mylan, Inc. to assure timely achievement of assigned goals.

A combination of experience and/or education will be taken into consideration.

Pay

The salary range for this position is $66,000 - $127,000, varying based on skills, experience, and location.

Benefits

Viatris offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.