Specialist Quality Assurance Supplier

Where

Groton, CT

What you'll be doing

Perform a range of duty within the pharm specialist quality assurance group, associated with quality system oversight and support of supplier and vendor program. Manage audit and re audit status for supplier and vendor, as applicable. Lead and support investigation of significant quality and regulatory event associated with quality system issue identified at external supplier and vendor. Monitor and report supplier and vendor quality system performance and risk rating. Communicate supplier and vendor quality performance issue and risk mitigation plan to appropriate compliance forum, vendor quality council and leadership. Review regulatory inspection outcome, determine impact and develop remediation plan. Identify quality continuous improvement effort to streamline compliance and efficiency. Perform risk based supplier assessment, as needed. Collaborate with quality operation to develop clear role and responsibility for supplier certification activity.

What your background should be

Prior quality assurance experience executing material approval and external party risk assessment of supplier and vendor is highly desirable. Prior experience with continuous improvement initiative is desirable. Detailed understanding and interpretation of the quality system and good manufacturing practice process for the research and development environment. Able to make moderately complex day to day decision and apply timely risk based decision making under minimal supervision. Excellent communication skill. Excellent collaboration skill.

Required Schooling / Training

Minimum bachelor degree or equivalent in a scientific discipline.

Who is the client company

This is an American multinational pharmaceutical corporation.

If you are interested in this position, send your resume to apply@kochdavis.com