Principal Specialist, Quality Assurance - Change Management

About the role

The Principal Specialist, Quality Assurance – Change Management leads and administers Quality Assurance activities related to change control, quality systems, and SAP master data management within the Nuclear & Precision Health Solutions (NPHS) PET manufacturing environment. This role applies cGMP and quality systems expertise to support complex projects, facility and product expansions, and cross-functional initiatives while ensuring compliance with regulatory requirements, quality standards, and internal procedures. The Principal Specialist serves as a key partner to Quality, Manufacturing, Purchasing, Engineering, and other stakeholders, providing guidance on change management processes, maintaining quality-related systems and data integrity, supporting electronic quality applications, and driving timely issue escalation and resolution. This position operates independently, develops innovative solutions to complex quality challenges, and may mentor colleagues to support continuous improvement and organizational objectives.

Responsibilities

• Quality Assurance administration and management of NPHS Change Controls
• Quality Assurance support/administration of various PET projects, including facility and product expansion
• Administrator for maintaining SAP master data of facility equipment for proper asset management and maintenance setup
• Administrator for maintaining SAP master data of materials, including primary and secondary inspection plans, and ensuring consistent quality control parameters, inspection characteristics, and sampling procedures in alignment with QMS standards
• Partner with Purchasing team to create new SAP materials, ensuring comprehensive documentation of all process steps required for accurate and compliant material setup within SAP
• Security Administration for NPS PET Manufacturing Services with Isotrac QA and Chromeleon programs
• Managing content and security in NPS PET Quality SharePoint site
• Network and work closely with cross-functional teams throughout NPHS to achieve positive outcomes
• Escalate issues to management in a timely manner
• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
• May contribute to the development of policies and procedures
• Works on complex projects of large scope
• Develops technical solutions to a wide range of difficult problems
• Completes work independently; receives general guidance on new projects
• Work reviewed for purpose of meeting objectives
• May act as a mentor to less experienced colleagues

Requirements

• Bachelor's degree in related field, or equivalent work experience, preferred
• 4-8 years of experience in the Pharmaceutical Industry or other regulated manufacturing industry preferred
• Heavy knowledge and experience with Microsoft Office programs
• Knowledge and experience in programs such as SAP, ISOtrac, Chromeleon, preferred
• Strong attention to detail
• Ability to manage timelines and priorities
• Ability to work independently with minimum guidance
• Ability to multi-task
• Travel expectations of 10% depending on business needs and project demands

Pay

Anticipated salary range: $80,900 - $103,950

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs