Associate Staff Quality Engineer

Position Summary:

The Associate Staff Quality Engineer is primarily responsible for managing the Nonconformance/CAPA systems for the Durham, NC site.  This is accomplished through tracking the process, scheduling and leading trending meetings, creating and monitoring quality performance metrics, implementation of related trainings and identifying continuous improvement opportunities.

Responsibilities:

• Develop reports, utilizing statistical tools where appropriate, identify and trend KPIs.  Collect and present metrics for site scorecard and Quality Systems Management Review.
• Oversee the site Investigator Certification Process, coach Investigators and assure adherence to SOP requirements.
• Support and/or perform quality investigation activities, including but not limited CAPA, Complaint, and Nonconformance
• Write, review, and approve SOPs to ensure they comply with the Quality System and current Good Manufacturing Practices
• Chair the NC/NCMR and CAPA trending meeting, and provide summary of data analysis to cross-functional team
• Serve as SME on NC/CAPA processes interface with customers and regulatory agencies for Inspections and Audits (MDSAP, FDA, ISO, Customer, etc)
• Support QMS Activities by participating in cross functional projects/activities
• Identify and implement continuous improvement activities to improve compliance to site, regulatory and industry standards.
• Perform any additional job related duties as requested

Studies and Experience:

• BA/BS Degree in a science related field preferred and a minimum five (5) years of experience working FDA regulated environment with knowledge of Good Manufacturing Practices required
• Minimum 10+ years GMP/FDA regulated industry experience required in lieu of degree
• Experience managing nonconformance quality system or extensive Investigation writing experience required.
• Competence in the selection and use of Quality Engineering Tools and Techniques
• Demonstrated ability in providing compliant and practical solutions to complex quality issues preferred

Knowledge, Skills & Abilities:

• Computer skills required, including TrackWise, TWD and Microsoft Office
• Excellent interpersonal skills and ability to work with all levels of an organization
• Ability to work independently and in a team environment
• Ability to prioritize and balance multiple deadlines in a fast-paced deadline driven environment
• Ability to work effectively and efficiently toward goal completion in a complex, diverse environment
• Ability to effectively communicate verbally and in writing; technical writing skills required