Keith Griffith Email & Phone Number

Summit, New Jersey, United States

• Quality manager collaborating with external vendors for cell therapy and viral vector materials.
• Engaged with vendor to enhance investigation processes to reduce review and closure times facilitating product release.
• Performed Person-in-Plant activities, providing feedback on clean-room manufacturing processes, managing operational relationships, and pursuing efficiencies with multiple on-site teams.
• Coordinated APQR process with vendors to meet annual internal regulatory document guidelines.
• Managed delivery of laboratory results between sites to facilitate timely Continuous Process Validation activity, including activation of a new manufacturing suite.
• Collaborated with extended vendor Quality and investigation teams to clear critical investigation backlogs.

Morgantown, WV

• Quality specialist engaging in a variety of supplier-facing accountabilities.
• Managed change administration for multiple vendor sites for patient-critical drug products.
• Built comprehensive change plans for multiple successful product transfers, mitigating risk to supply chain and preventing gaps in market availability of lifesaving products.
• Performed assessment for sites flagged by the risk team, identifying sources of potential harm to customers or adulterated product.
• Evaluated site APR documents for completeness and gaps in provided documentation to ensure regulatory and quality assessments were up-to-date.
• Coordinated compendial update needs with internal team to maintain compliance.

Morgantown, WV

Independent Pharma and Cosmetic Quality Assurance contractor with expertise in document creation and management, systems development, personnel management, troubleshooting, and auditing.

Kannapolis, NC

Responsible for all aspects of Quality and Compliance systems along with management of other individuals in related tasks. Manages a diverse team across multiple business locations.Customer Audit Lead. Product Failure Investigation and Root Cause Analysis. Coordinate Document Control teams to manage production demands. Responsible for Customer Complaint.

Kannapolis, NC

Responsible for managing and developing Compliance and Quality systems relating to Complaints, Annual Product Reviews, and CAPA.

Kannapolis, NC

Supervisor of Quality Assurance Operations, Testing, and Documentation groups.