PQA, Quality Professional

Manager Summary:

Our team of 15 Quality Professions is dedicated to implementing and maintaining the effectiveness of the Quality System by performing complaint evaluations/investigations and customer responses in a timely and compliant manner to meet both customer and regulatory expectations. We support associated processes such as audits, complaint reviews, and replies to regulatory agencies regarding specific complaints.

Summary:

Conduct quality-related activities to deliver consistent,high quality documents,services,products and processes,which adds value to the business.

Main Responsibilities:

General - Contributes to defining and timely achievement of overall project goals.

Provides compliant solutions to a variety of problems of moderate scope and complexity.

Interacts constructively with employees,managers and cross-functional peers.

May lead a project with a limited scope,but usually a contributor on broader projects.

Provides guidance to other Professionals and Technicians.

Scope typically limited to one specific QA function.

Quality System Compliance -Maintains awareness of standards that regulate our industry.

Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.

Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.

Risk Managment - Applies basic Risk Management principles to work.

Participates in the development or modification of Risk anagement files.

Complaint Evaluation - Investigates complex complaints with management oversight.

Provides compliant solutions to a variety of complex problems.

Ensures compliant documentation related to area of responsibility.

Design Control / Documentation & Change Control - Identifies areas for process improvement.

Provides supporting information for change including reasons and justifications.

Quality Engineering - Coordinates quality decisions between different quality and engineering groups.

Participates in the development or modification of validation packages,design plans,and risk management deliverables (e.g.

FMEAs). Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.

Qualifications:

Apprenticeship or Bachelor’s degree in Life Science,Engineering,or closely related discipline is required OR relevant combination of education or experience. At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree. Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.