Mark Woolliscroft Email & Phone Number

Perform Batch Record review of commercial final product. Perform AQL visual inspection of commercial filled vials. Document QA Holds that are issued to assists in the identification of risk and deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements.

• Perform final product inspection and release of all commercial medical devices. Generate Certificate of Conformance for customer’s orders following verification of sterility testing results. Conduct batch record.
• Review completed manufacturing batch records for compliance to cGMP standards.
• Generate Certificate of Analysis as part of final release of IVBG sensor and tubing kits.
• Propose document changes to standard operating procedures (SOPs), and lot history records (LHRs) to ensure regulatory compliance.
• Conduct in-process medical device inspections and LHR documentation reviews of all records prior to release for use in clinical studies.
• Conduct final product kit inspections and batch record reviews prior to final product release for shipment.

Analyze analytical test data results from Contract Laboratories for commercial release of drug product and drug substance lots.Performed analytical reviews of various test results from AAA, pH, Osmolality, Bioburden, Sterility, Endotoxin and RP / SCX-HPLC testing to ensure purity and potency of the drug substance and drug product lots.Generated Certificate.

Conduct final product testing and release on all commercial medical devices.Scheduled and performed process verification compliance reviews to confirm that assembly and testing documents were up to date per FDA regulatory standards.Confirmed that safety, training, product labeling, tooling and shelf life requirements were correctly implemented and being.