Description Overview

As a Quality Assurance Engineer, you will support and participate in continuous improvement activities in the operations areas. This person will provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMI and ensures that all information and documentation conforms to company policy, cGMP's and all other applicable FDA guidance's.

Please note: This role is currently structured as 4 days onsite, 1 day remote.

Scope of the Role

• Leads/Participates in quality driven initiatives in the continuous support of Quality improvements, using data analysis techniques and other improvement tools.
• Responsible for reviewing and approving documents such as deviations, Annual product reports, non-routine batch status change requests, planned deviations, calibration non conformances, etc.
• Provides initial risk assessment of Quality events.
• Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality.

Experience Required

• Bachelor's Degree in a scientific discipline or closely aligned field, with a minimum of two years experience working in an FDA regulated industry, preferred.
• Demonstrated understanding and application of Continuous Improvement and Root Cause analysis skills.
• Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements in an FDA regulated industry.
• Strong functional knowledge of SAP systems.
• Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines.