John McCrillis
Chemist, Biotechnology Professional, and CMC in Rhode Island
Quality Control professional with expertise in method development, method validation, method transfers and project management.
Problem solver providing creative solutions to complex problems and making quality decisions to meet business needs.
Leader with management experience that helps to develop staff and meet business goals.
· Experience supporting high level company initiatives to improve quality systems with strong experience in generation of protocols, deviations, CAPAs, SOPs, and laboratory investigations.
· Roles with responsibilities in training, leading and supervising staff, applying technical and conceptual skills.
· Strong experience in instrument qualifications. Generation of URS, Gap Protocols and Reports. Execution of IQ, OQ and PQ for laboratory equipment.
· 11+ years in the biopharmaceutical industry successfully supporting cGMP and FDA regulated operations.
· Provided technical support as QC Analytics SME during regulatory inspections, including acting as tour lead for QC Analytical Laboratories.
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