Sr. Quality Assurance Project Specialist

Sr. Quality Assurance Project Specialist – 30668

Contract

Major responsibilities include:
The Packaging Supplier QA Sr. Project Leader should exhibit excellent communication and leadership skills and support the training and development of Associate Project Leaders and Project Leaders in the department. The Sr. Project Leader will be expected to manage more projects with a larger scope and complexity.

• Provide support to global operations by resolving packaging incoming material issues in a timely manner. Work with plants to develop sampling and correction plans when resolving packaging issues within received lots.
• Manage packaging supplier recurring CAPAs on a monthly, quarterly and annual basis by evaluating exception report data and reporting information to appropriate areas of the business (i.e. Purchasing and Operations), as well as the suppliers.
• Support resolution and approval of exception reports within the plants. Lead investigations to resolve and troubleshoot supplier processing or packaging issues.
• Monitor packaging complaints monthly and quarterly and identify and resolve trends within packaging categories.
• Responsible for maintaining/controlling the approved supplier status of suppliers.
• Perform supplier qualification assessments of new packaging suppliers to assure the quality design of the package and the supplier’s processes, facilities and systems meet AN and regulatory requirements. Work with Package Development to develop, validate and issue packaging methodology and equipment. Conduct equipment R&R studies at qualification to assure that testing between plant and suppliers is in alignment.
• Develop packaging suppliers’ systems and processes to improve process capability and to develop certificates of analysis. Assure appropriate supplier in‑line equipment is validated.
• Conduct reviews and updates to supplier regulatory documentation that is submitted with all packaging changes and new qualifications to assure regulatory compliance.
• Maintain relevant documentation such as SQA policies, procedures, specifications, and acceptance programs and assure these documents are current and compliant to internal policies and regulations.
• Assure that proposed changes made to supplier processes are approved and compliant to specifications, making changes when necessary.

Bachelor's degree in engineering, scientific or technical area with 3-5 experience in quality or package engineering.