Tanner Morrison Email & Phone Number

United States

Schedule and Host 30+ Client/FDA/EMA/QP audits annually.Supervision and Review of the Raw Materials/Finished Product Testing Group.Writing and Performing 30+ Trend Reports annually for GMP compliance.Responsible for maintaing the University of Iowa Pharmaceuticals manufacturing site as well as our contracting labs in a state of compliance with cGMP, FDA, EU, and internal regulations for clinical and commercial production. Perform internal audits of UIP departments and external audits of our contracting labs to assure adherence to internal and external controls.

Calibration and Maintenance of various pieces of pharmaceutical manufacturing equipment following FDA, GMP, and NIST guidelines. Write Protocols and execute Temperature Mapping of Storage Chambers and Rooms throughout UIP Facilities to assure they meet ICH guidelines.Batch Record/Document review of contracting company production records to assure correctness of the manufacturing records.Write and Evaluate SOPs, Protocols, and various other technical documents for compliance with cGMP and FDA guidelines.Operate and Maintain Database used for tracking all calibration and maintenance schedules of equipment and systems used in GMP manufacturing.Operate and Maintain Database used for training and tracking of over 700 SOPs for 30+ employees.

Visual Inspection of manufactured drug products including liquid fills, lyophilized product, tablets/capsules, gel filled tubes, and syringes.Produced labels according to client supplied specifications for labeling of various drug products.

Bachelor Of Science (B.S.), Biology, General

Education record