Keith Griffith

Keith Griffith Email and Phone Number

Pharmaceutical Quality Assurance Professional | Documentation, CAPA, Investigations, and Change Systems | ASQ Certified @ The FDA Group
westborough, massachusetts, united states
Keith Griffith's Location
Greater Pittsburgh Region, United States
Keith Griffith's Contact Details

Keith Griffith personal email

n/a
About Keith Griffith

Accomplished Quality and Compliance Systems Professional with a robust track record in managing and enhancing Quality and Compliance operations. Demonstrates expertise in leading teams to achieve corporate production goals while ensuring adherence to stringent quality standards across multiple internal and external sites. Skilled in vendor oversight, strategic planning, and change control, with a strong background in GMP and regulatory compliance. Proficient in managing complex relationships with vendors and customers, delivering significant improvements in process efficiencies and compliance outcomes, making an asset to any organization.

Keith Griffith's Current Company Details
The FDA Group

The Fda Group

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Pharmaceutical Quality Assurance Professional | Documentation, CAPA, Investigations, and Change Systems | ASQ Certified
westborough, massachusetts, united states
Website:
thefdagroup.com
Employees:
45
Keith Griffith Work Experience Details
  • The Fda Group
    Consultant
    The Fda Group Oct 2024 - Present
  • Bristol Myers Squibb
    Manager External Quality – Vector & Plasmid Cmos
    Bristol Myers Squibb Jul 2022 - May 2024
    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.• Provided back-end support for multiple regulatory agency audits for new commercial sites and spaces.
  • Viatris
    Senior Specialist, Na Quality
    Viatris Aug 2018 - Oct 2021
    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.
  • Self-Employed
    Quality Assurance Consultant
    Self-Employed Sep 2017 - Aug 2018
    Morgantown, Wv
    Independent Pharma and Cosmetic Quality Assurance contractor with expertise in document creation and management, systems development, personnel management, troubleshooting, and auditing.
  • Ei - A Pharmaceutical Solutionworks™
    Quality Systems Manager
    Ei - A Pharmaceutical Solutionworks™ Nov 2013 - Jun 2016
    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 resolution and Annual Product Review. System Administrator for Master Control QMS.
  • Ei - A Pharmaceutical Solutionworks™
    Compliance Manager
    Ei - A Pharmaceutical Solutionworks™ Oct 2009 - Nov 2013
    Kannapolis, Nc
    Responsible for managing and developing Compliance and Quality systems relating to Complaints, Annual Product Reviews, and CAPA.
  • Ei - A Pharmaceutical Solutionworks™
    Quality Assurance Supervisor
    Ei - A Pharmaceutical Solutionworks™ Jan 2007 - Oct 2009
    Kannapolis, Nc
    Supervisor of Quality Assurance Operations, Testing, and Documentation groups.

Keith Griffith Skills

Quality Assurance Quality Control Gmp Quality Management Quality Auditing Sop Standard Operating Procedure Quality System Fda Gmp Systems Development Team Building Continuous Process Improvement Annual Product Review

Keith Griffith Education Details

Frequently Asked Questions about Keith Griffith

What company does Keith Griffith work for?

Keith Griffith works for The Fda Group

What is Keith Griffith's role at the current company?

Keith Griffith's current role is Pharmaceutical Quality Assurance Professional | Documentation, CAPA, Investigations, and Change Systems | ASQ Certified.

What is Keith Griffith's email address?

Keith Griffith's email address is kg****@****rks.com

What schools did Keith Griffith attend?

Keith Griffith attended Concord University.

What skills is Keith Griffith known for?

Keith Griffith has skills like Quality Assurance, Quality Control, Gmp, Quality Management, Quality Auditing, Sop, Standard Operating Procedure, Quality System, Fda Gmp, Systems Development, Team Building, Continuous Process Improvement.

Who are Keith Griffith's colleagues?

Keith Griffith's colleagues are Lara Gonzalez-Ruiz Director At Lgz Quality Services Ltd, Susannah Rogers, Antonio Anjasmara, Alan G., Nain Singh, Maria Veronica Diaz, Cheryl Wagoner.

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