Cheryl Kitchen Email & Phone Number

Durham, North Carolina, United States

Greater Philadelphia Area

Lead a team of Quality Assurance professionals at two multi-product API commercial manufacturing facilities.• Ensured Quality’s goals were in alignment with company objectives and regulatory expectations with a focus on right-the-first-time, continuous improvement, KPIs, compliance, and safety. • Implemented, harmonized and maintained the Quality Management System at two facilities to allow cross site collaboration and compliance. • Steered and focused the investigations of significant deviations, out of specifications, customer complaints and provided the oversight to ensure effective CAPA were implemented.• Hosted two successful FDA inspections and numerous customer audits, motivated on ensuring that the facilities were continually in a state of “Inspection Ready.”• Oversight over the daily quality pharmaceutical manufacturing responsibilities (managed; batch release process, approval of master records, document control, quality systems, specifications, procedures, test methods, internal and external audits, validation and qualifications) ensuring resources, timelines and expectations were being met.

Developed and implemented a phase appropriate Quality Management System for start-up pharmaceutical manufacturing company.• Quality oversight over all cGMP, GLP and GCP work performed, both internal and external, as drugs moved from non-clinical to clinical phase development.• Approval of master records, specifications, procedures, test methods, validations, qualifications and other GMP documents. • Investigated deviations and out of specifications and provide support for CAPA implementation.

Raleigh-Durham, North Carolina Area

Coached and managed the Batch Release team of commercial and clinical Biotechnology API products. • Primary approver of master records, specifications, procedures and other GMP documents. • Lead internal audits and participate in regulatory and customer audit and ensured the site operated in a state of permanent inspection readiness. • Revised the stability program to ensure sustainable compliance. Authored stability procedures, protocols, review and approve stability reports and performed investigations. • Represented the company to clients and in an inter-departmental cross functional matrix. Duties included GMP compliance oversight and batch release for manufacturing projects of significant scope.

Raleigh-Durham, North Carolina Area

Cardinal Health PTS is a contract testing and clinical manufacturing facility.•Assessment of compliance for release of all clinical batch production, packaging and testing through batch review and investigation.•Data review of synthetic chemistry records and formulation activities.•Auditing test method development and method validation data, cleaning verification methods, batch records and formulation data.•Quality review of laboratory data. Reviewed and approved certificates of analysis and reports to customers.•Investigation of out of specification data and deviations and collaborate with corrective action planning. •Supervised a team of professionals and provided GMP training to all staff.

Winnipeg, Canada Area

Cangene Corporation is a manufacturer of specialty parenteral, biotech products with aseptic product processing, lyophilization, sterile filling and packaging.•Ensure that the quality of work met the requirements of the contracting companies while maintaining cGMP compliance. •Responsible for lot release and batch record review, test results review, investigation completion and corrective action planning.•Review and approved master batch records and standard operating procedures.•Preformed routine and for-cause internal audits throughout the company.•Assist with client and regulatory audits.•Supervised professional staff.