Job Title: QA Investigator

Work Location: Caldwell County, North Carolina

Summary:

The QA Investigator is responsible for conducting investigations from open to close, ensuring that the QA person is performing the investigation rather than the individual who caused the event. The role requires strong root cause analysis skills, technical writing, and the ability to work within a small team. Garbing/aseptic experience is a plus, and candidates must be willing to obtain garbing certification. The position supports regulatory inspections, media fills, and participates in audits.

Responsibilities:

• Technical writing skills
• Critical thinking skills and detail oriented
• Creation of general business documents and procedures
• Understanding of applicable governmental regulations
• Participates in internal and external audits, travel may apply
• Communicates issues to Quality Management
• Ability to collaborate as a member of cross-functional teams
• Support regulatory inspections
• Support media fills
• Additional tasks as required

Performs/reviews the following as applicable by functional unit:

• Deviations
• Complaints
• Discrepant Material reports
• Laboratory Out of Limits
• Building Monitoring System Out of Limits
• Calibration Out of Tolerance
• Product Out of Yield
• Corrective/Preventative Action reports
• Critical System Work Orders
• Change Notifications
• Change Requests
• Document revisions
• Protocols
• Compilation of metrics

Qualifications:

• Bachelor’s degree in a scientific field
• 2-5 years of pharmaceutical manufacturing experience (or post-secondary education) is required
• Root cause analysis experience is required (experience with tools such as 6M, 5 Whys, fishbone, and other methodologies preferred)
• Garbing/aseptic experience is a plus; must be willing to obtain garbing certification
• Experience working in or willingness to work in a small team environment (around 5 people)
• Technical writing skills
• Critical thinking skills and detail oriented
• Ability to create general business documents and procedures
• Understanding of applicable governmental regulations
• Ability to participate in internal and external audits (travel may apply)
• Ability to communicate issues to Quality Management
• Ability to collaborate as a member of cross-functional teams
• Ability to support regulatory inspections and media fills
• Requires Type 4 Garb qualification (Sterile Containment Suit, Sterile Hood, Sterile Face Mask, Sterile Gloves, Sterile Boots, and Sterile Goggles)
• Must be able to pass visual acuity test
• While performing the duties of this job, the employee is frequently required to sit, talk, and hear
• Specific vision abilities required include close vision and ability to adjust focus
• Basic computer knowledge such as Word Processing and Database software as well as Edwards or equivalent inventory software
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Published Category: Quality & Validation