Monitor manufacturing operation for compliance to Standard Operating Procedures (SOP’s) and batch records.   In addition, ensures that all products are manufactured accurately.  

MAJOR ACTIVITIES AND RESPONSIBILITIES

• Monitor facilities operations to assure compliance with current Good Manufacturing Practices (cGMP’s) and written procedures.
• Perform internal audits of all Quality Systems within the facilities.
• Perform external audits of Vendors of raw materials/components/contract manufacturers and labs
• Working knowledge of cGMP’s and FDA Guidance Documents.
• Investigate deviations
• Evaluate cGMP documentation for accuracy/revisions
• Ability to work overtime, extended shifts, and occasional weekends

BACKGROUND REQUIREMENTS

• Bachelors degree in a science related field and 2-3 years experience in a quality related field
• Knowledge of manufacturing operations
• Good technical writing and computer skills
• Good organization and communication skills
• Ability to interact with many departments