Essential Duties And Responsibilities Include The Following As Assigned:
Complete Customer Quality Surveys & Questionnaires
Coordinate Quality / Technical data requests: such as Customer Spec Sheets, or Certificates of Origin, Stability Data, GMP Certifications, etc.
Perform Internal Quality Audits
Assist in hosting Customer Quality System Audits and or Regulatory Inspections
Maintain and continual development of Scientific Documentation/Quality Response Package Maintain Supplier Qualification Program
Maintain Customer Change Control Program and Notification Support to affected parties
Assist with quality investigations
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Knowledge of Quality System requirements of ISO 9001:2015, current Good Manufacturing Practices 21 CFR 210& 211, IPEC PQG, and ICH Q7/A.
Must have basic computer literacy including familiarity of programs such as Word, Excel and Pagemaker, Filemaker.
Bachelor's degree (BA/BS) from four-year college or university. Training in Quality System Auditing highly desired.
Lean process improvement and Six Sigma, 5 S experience and background preferred