Robert Bottomley Email & Phone Number

Chicago, IL, US

Lafox, IL, US

• Led MRB cross-functional team meetings to review operational non-conformances. Performed root cause analysis, and implemented corrective actions to address product issues.
• Managed supplier quality department. Duties included supplier approval/monitoring, working with suppliers to implement CAPA actions relating to supplier non-conformances, and completing PPAP and supplier fair paperwork.
• Managed internal audit process. Duties included audit schedule management, new auditor training, performing ISO audits, and implementing CAPA actions to address audit findings.

• Managed Document Control department at Fareva Morton Grove facility. Duties included managing controlled documents throughout their lifecycle, periodic review and updating of operational standard operating procedures.
• Performed investigation of product non-conformances using industry standard techniques such as 5-Y, fishbone, and fault-tree analysis. Implemented CAPA actions to address these findings, and monitored CAPA.
• Completed validations for operations (IQ, OQ, and PQ). Duties included writing and reviewing validation protocols and reports.
• Prepared annual drug product review reports.

Bridgewater, New Jersey, US

Responsible for managing all MQA activities including Line Inspection, Manufacturing Deviations, Cell Line Inventory, Batch Record Review. Document Issuance and Review. Assist in administration of critical QMS systems for Deviation, CAPA, Change Control, and Laboratory OOS. Participate in laboratory and deviation investigation writing as needed. Perform.

Bridgewater, New Jersey, US

Managed Supplier Quality program with duties including supplier maintenance(review of supplier change notifications, periodic risk assessment, maintenance of supplier agreements), supplier approval (reviewing supplier compliance against FDA CFR requirements, coordinating site audits as needed, completing risk assessments), and supplier disapproval.Managed.

San Diego, CA, US

Performed laboratory OOS and Deviation Investigations. Performed root cause analysis investigations.cGMP QC testing and data review. Technical troubleshooting of lab automation. Supported assay integration and improvement efforts. Managed Assay Improvement projects for the Tecan Liquid Handling System. Programming of Tecan scripts in support of assay.

San Diego, California, US

General management of QC Department.

QC testing of injectable products via various lab methods.Aseptic processing and cell culture of Leishmania tropica.Fill finish operations for injectable productsManaged stability testing of multiple FDA approved injectable products.

HPLC Method DevelopmentPrepared Customer COAcGMP QC TestingRevised Test Method SOPs

San Diego, CA, US

QC release testing of various GMP products.Participated in regular FDA audit activities.GMP Manufacturing purification of antibodies via Size Exclusion, Ion Exchange, and Affinity Chromatography.Training of chemists on manufacturing processes.Wrote and revised manufacturing SOPS