Job Description

• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to equipment used records, work orders, job plans, reports and batch records.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
• Complete required assigned training for self to permit execution of required tasks.
• Perform training activities, as needed.
• Support operational improvement initiatives, programs and projects.
  Perform walkthroughs/inspections of areas to ensure housekeeping and GMP are maintained

• Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
• Strong cGMP and GDP behaviors
• Strong word processing, presentation, database and spreadsheet application skills
• Strong organizational skills and ability to manage multiple tasks at one time
• Knowledge of electronic systems including LIMS, Trackwise, and Maximo.

• Ability to work in teams, flexible to work in an everchanging work environment
• Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
• Strong cGMP and GDP behavior