Essential Job Functions:
- Responsible for Document Control System including Documents, Forms, Quality Manual, Work Instructions.
- Responsible for Q.C. processes including in-process inspection, batch record review, finished product inspection, receiving inspection.
- Responsible for Quality Investigations, Non-Conforming Product, Complaint reporting, Internal audits, corrective actions.
- Regulatory Compliance including medical device/drug facility registrations, FDA drug listings, Supplier reviews, GMP and compliance to FDA regulations.
- Oversee the documentation training, safety training and verification of training and audit records.
- Environmental monitoring including Warehouse temperature recording and pest control.
- Safety Manager responsible for safety meetings, safety audits, overseeing all applicable safety training.
- Designated Quality Management Representative/Management Review.
- Knowledge of FDA/GMP compliance regulations including ISO elements and CFR’s.
- Internal Audit experience either FDA or ISO.
- Knowledge of Quality System Management and documentation requirements.
- Intermediate computer skills including Word, Excel, Power Point, Outlook and other applications as needed.
- Supervisory experience.
- Safety/Environmental experience
- Document Control experience
Indeed - 12 months ago