Cathy Kroskey Email & Phone Number

Hollis, Nh, Us

Lexington, Massachusetts, United States

Framingham, Massachusetts, United States

Responsible for development, implementation and maintenance of Quality Assurance systems and activities. Ensured all relevant quality and regulatory requirements are met for manufacture and testing. Ensured site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies. Responsible for evaluation and assurance that appropriate quality systems were in place at approved vendors and suppliers supporting GxP. Developed, managed, and mentored the QA staff performing release and compliance functions.• Oversaw Replimune Compliance and Quality systems: audit, vendor qualification and audits, change control, deviation and investigation management, corrective and preventive action systems, QC release testing.• Managed batch review and disposition processes of Replimune products.

Framingham, Massachusetts, United States

Responsible for quality oversight of facility, utilities, and equipment validation of newly built manufacturing and laboratory facility. Developed the Quality Assurance team including identification, staff training development, performance management, coaching, and mentoring. Provided guidance in the document design for process SOPs, batch records, analytical methods, and various forms and reports. Implemented deviation and CAPA triage to classify and manage records.Managed the Quality Systems unit providing continued leadership and support of the document control system, training program, and ongoing process optimization for improved user experience.

Woburn, Massachusetts

Woburn, Massachusetts

Lead Investigator, Deviations / Nonconformances. Including Standard Root Cause Analysis, Fault Tree Analysis, Causal Factor Analysis

Woburn, Ma

Quality Assurance nonconformance investigator.

Boulder, Co

Manufacturing nonconformance investigator. Responsibilities included investigating and writing nonconformance records using TrackWise database; SRCA (Standard Root Cause Analysis); product impact; and evaluation and implementation of corrective / preventive actions. Present and defend records to agency inspectors (FDA, EMEA, Canadian) and internal audit teams.Additional experience in manufacturing dispensing and warehousing operations, SAP, in-house audit program.

Supervised contract cleaning staff and one FT staff member for 2 commercial manufacturing facilities and 4 research buildings; space planning and move coordination for manufacturing facility; intermediary between facilities maintenance group and their customers, which included follow up work requests and investigate problems; maintain gowning and cleaning supplies. Provided GMP introductory training for contractors and job training for clean room cleaning staff. Manage pest control program for commercial manufacturing facility. Building access manager - developed security access plan for production areas.

Building Services Manager 3/92-9/94Supervise Lab Support Facilities (media prep and dishwashing facilities) for 5 buildings; space planning for a 700+ employee population in 6 buildings (430,000 sq. ft.); provide input for remodeling projects and new facilities; developed, maintained, and monitored departmental budget. Supervised a department staff of 22 full-time employees.Laboratory Coordinator 8/87-3/92Supervised lab support facility for research oriented building. Included hiring and training of support staff; purchasing consumables; equipment repair, maintenance, and scheduling; move coordination and general support for scientific and administrative personnel.Laboratory Technician 1/86-8/87Responsible for media preparation and glassware washing, packaging and sterilization of supplies, consumables inventory, and general lab support.

Bs, Botany & Plant Pathology

Aas, Wildlife Bioloty

Bachelor Of Science - Bs, Botany/Plant Biology

Associate Of Arts And Sciences - Aas, Wildlife Biology