Clients have included Medical Device, Combo Products, Solid Dose, Large Molecules, Biologics, Aseptic and Terminally Sterilized Drug Product Manufacturers.Managed the supplier quality program as well as a team of consultants in remediating the supplier quality program. Directed the QC Microbiology, QC Chemistry, and Supplier Quality Departments as Interim Quality Control Manager.Completed regulatory agency (FDA, EMA, etc.) commitments.Established and composed policies and supporting procedures/documents for Environmental Monitoring (EM), validation, training, supplier management, and materials management programs. Developed and performed equipment validation, revalidation, and decommissioning protocols. Led a team of consultants for investigation remediation and CAPA closure.Completed in-depth trend investigations as well as manufacturing and customer complaint investigations with effective CAPAs.

Managed 15-30 Production employees for the Compression, Encapsulation, and Coating Department.Ensured the timely manufacture and release of product meeting customer demand while aligning production activity with Site productivity and Lean goals and objectives.Performed timely review and closure of department investigations, CAPAs, and revisions to batch records and SOPs to maintain compliance with cGMPs.Mentored colleagues in investigation and CAPA writing to promote individual development.

Performed manufacturing and customer complaint investigations that clearly state events, determination of root cause(s), and appropriate CAPA(s) concentrating on operations, production equipment, and instrumentation as well as assisting in the closure of CAPA’s.

Managed the investigation workload for six (6) Compliance Engineers ensuring investigations were assigned and completed on-time.Developed and managed the Site’s Calibration Reliability and Preventive Maintenance programs identifying poor performing instruments and equipment, standardizing instruments, and revising preventive maintenance instructions reducing instrument and equipment failures.Developed and managed the Site’s Engineering Change Management program ensuring changes to equipment and processes during a project were documented and tested.Led a cross-functional team in developing project engineering procedures based on ISPE Good Engineering Practices reducing the time for projects to be completed which increased production time.Performed investigations on utilities, manufacturing equipment, and instrumentation to determine root cause and appropriate CAPAs preventing future occurrences and ensuring acceptable product was released for further processing.Led a team from Engineering on a gap assessment to ensure Engineering procedures aligned with corporate conformance standards ensuring site compliance to industry standards.

Managed 5-20 Manufacturing Quality Assurance employees for the Small Volume Parenteral (SVP) manufacturing area.Collaborated with manufacturing management to resolve real-time quality issues minimizing production downtime while ensuring product quality.Planned and assigned work operations for Quality Inspectors ensuring on-time quality Sampling of in-process and final product.Performed batch record review and disposition of product ensuring timely release of product meeting customer demand.Qualified the visual inspection process for a new packaging line.

Performed daily walk-through audits of the SVP Manufacturing Area ensuring compliance with SOP’s, cGMP’s, and safety requirements ensuring the manufacturing area was in a state of audit readiness.Performed in-process and final product testing (percent Oxygen in headspace, visible particulate, and visual defects of container and container closure) to ensure product met specifications per batch records and SOP’s.

Performed environmental monitoring sampling of the Aseptic Manufacturing Area as well as a variety of biological assays on in-process, final product, and environmental samples.