QA Specialist (closed)
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
- 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