Michael Bonar Email & Phone Number

Bryan, Tx, Us

Billingham, Gb

Provide quality management system (QMS) services such as Deviation Investigations, Root Cause Analysis, Corrective Action and Preventative Action, Design Controls, Complaint Investigations, and Process Improvement and Troubleshooting.

North Augusta, Sc, Us

Lead Associate reviewing and approving deviation investigations. Perform Root Cause Analysis for investigations. Quality role for Industry-scale manufacture of proprietary and generic peptides and specialty chemicals, used as active pharmaceutical ingredients (APIs), review contract research data and manufacturing services for pharmaceutical, biotech and research organizations in the biopharmaceutical area, review and approve Fill/finish and formulation development for peptide, protein and other injectable drugs, and quality oversight of manufacturing and marketing peptide, protein and other biopharmaceutical drug products.

Irvine, California, Us

Complete and document deviation investigations related to oral solids and packaging area.Propose corrective and preventative actions to address root causes of deviations.Work with operations, technical support groups and quality assurance to ensure thorough investigation of deviations.Trend deviations within drug products to look for common causes of deviations. Reduce recurrence of the deviations. Reduce backlogs of accumulated deviation.

Raleigh, North Carolina, Us

Senior Consultant for Strategic Sourcing and Procurement group at Regeneron. Responsibilities include CAPA closures for backlog of events, Vendor classifications, Supplier Corrective Actions Reports (SCARS), performing deviation investigations, risk assessment, and adverse event reporting.

City Of London, London, Gb

Senior Consultant for Strategic Sourcing and Procurement group at Regeneron. Responsibilities include CAPA closures for backlog of events, Vendor classifications, Supplier Corrective Actions Reports (SCARS), performing deviation investigations, risk assessment, and adverse event reporting.

City Of London, London, Gb

Santa Barbara, Ca, Us

Dublin, Ie

Senior quality associate working in QA Complaints for biotechnology company. Review and Approve quality documents and track and trend complaints for combination drug/device products. Investigate complaints by batch record reviews. Interact with offsite call center to determine if information is applicable to the complaint.

Essen, Nrw, De

Assures the quality and compliance of drug delivery components and API's.. Process owner for company internal audit system, supplier quality and quality systems training program. Project management for updating and ownership of CAPA's and final batch review and release.

Assures the quality and compliance of manufactured class II medical devices. Process owner for company internal audit system, supplier quality and quality systems training program. Project management for updating and ownership of CAPA's and specialty projects as assigned by Quality Manager.

Frisco, Tx, Us

Complaints investigator for medical device manufacturer. Third party supplier to client manufaturer.

Deerfield, Illinois, Us

Consultant for Baxter doing risk assessments, field actions, and reducing deviation back log.

Wayne, Pa, Us

Providing consulting to a contract manufacturer in a parenteral processing facility. Working with FTE on deviation investigations and report writing. Reducing their backlog of investigations and CAPA's. Providing sound root cause analysis and prevention of recurrence.

Beverly, Massachusetts, Us

Subject Matter Expert on Water systems and sampling. Wrote and revised SOP. Gap analysis, internal audits for the Global Remediation Quality Team

Bloomington, Us

Quality Specialist for Contract Manufacturing Organization (CMO). Review batch records for Preclinical and Clinical Trials, on the floor support for manufacturing of the drug substance division (Active Pharmaceutical Ingredient-API), and lead a team of 6 quality professionals

Lake Forest, Il, Us

Deviation investigation to determine root cause by conducting personnel interviews and system reviewsImplement corrective and preventative actions (CAPA) Evaluate CAPA in regards by trending and effectiveness checksWork with manufacturing to create a climate of continuous improvement

Delivery Device Assembly OperationsApprove component and finished product (Apollo insulin pens) batch records adjusting to meet country/customer requirementsPartner with operations to create a climate of continuous process improvement using six sigma management philosophiesInventory control and product release for worldwide distribution using SAPReduce the number of batch reworks and rejectsGenerate monthly metrics for upper management using TrackwiseMaintain quality systems ensuring compliance with device assembly process orders

API ManufacturingRoot Cause Analysis for InvestigationsReview and Approve manufacturing deviations in Trackwise and GIMS databasesReview and Approve change controls in Trackwise and GCMS databaseReview and Approve manufacturing tickets and job aides in RegulusMaintain quality systems ensuring compliance with manufacturing tickets and proceduresAuditing and inspecting production areas to ensure cGMP complianceCoordinate sampling for stability studies for insulin APIQuality technical expert for environmental monitoring of ISO classified areasWrite and revise quality agreements with other Lilly sitesManage and control inventory movements in SAPCoordinate analytical Additional Test RequestsConduct Manufacturing Investigations and root cause investigationsReview and Approve technical documents and Manufacturing Logbooks

Thousand Oaks, Ca, Us

Testing of clinical trial material prior to scale up productionPerform chemical analysis in the lab using appropriate pharmacopia (i.e. USP, EP, JP)Develop weekly testing schedules for staff using SAP databaseReview and approve lab notebooks and analytical resultsMaintain Compliance with CFRs, cGMPs, SOPs, and Amgen policiesDisposition of raw materialsMentor new staff and Train technicians on procedures Pour plate and membrane filtration analysis of water samples

Switzerland 🇨🇭 , Ch

Lead shifts of QC Analysts by coordinating activities of lab personnelMethod qualification and validationInterview and hire new techniciansEvaluate and write performance reviews for 24-member lab staffSupervise and train techniciansPerform routine and advanced analysis on samplesPerform out of spec investigations and make the final disposition of intermediates and APIsDisposition of APIs and pharmaceutical intermediatesUpdated the training program for new techniciansSOP and method reviews and updates