QA Technician, Finishing

Position Summary:

The Technician I, QA - Finishing provides direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with federal regulations for current Good Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing activities performed during finishing operations.

Job Responsibilities:

· Monitors pharmaceutical operations in daily inspection activities to ensure personnel are following procedures

· Perform QA inspection of finished drug product units and samples for release/stability testing

· Manages reject cage for rejected finished drug products

· Administer/ prepare inspector qualification tests when needed

· Assist in writing, revising, & reviewing SOPs for applicable areas

· Provide QA oversight to pharmaceutical Operations and perform acceptance quality limit (AQL) inspection

· Perform Quality Assurance compliance review of manufacturing, maintenance, and quality logbooks and records

· Assist in routine filing of Quality records

· Perform bi-weekly and monthly quality walkthroughs of various cleanroom classified locations

· Perform logbook review

· Perform other duties as assigned

Required Skills:

· Excellent interpersonal skills and the ability to communicate well orally and in writing

· Ability to multi-task and handle multiple priorities in a dynamic environment with changing priorities

· Attention to details

· Team player willing to work with everyone

Education and Experience Requirements:

· Bachelor’s degree in a science or related field is strongly desired, or High School diploma with 3 years relevant GMP or regulated industry experience

· Experience supporting manufacturing is preferred

· Experience with computers, including Microsoft Office, Windows