Corey Sutton Email & Phone Number

Latham, New York, United States

Massachusetts, United States

Lee, Massachusetts, United States

Spring Valley, New York

Maryland

Run all aspects of event Public Safety for Onezumi Events at various events.

Middleburgh, New York

Albany, New York Area

Rensselaer,Ny

Facilitates all reviews and revisions of all Facilities Department related SOP's, plans and policies for each group within the Department.Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.Provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as MC's, NOE's, and DNF's, impact statements and corrective action plans.Investigator for non-compliance/deviation issues including writing investigations and root cause analysis for all Facilities Department deviations. Provides tracking and trending for all facilities and maintenance related compliance activities i.e. NOEs, HEPA Filter, Calibrations, OOT, Water Systems.Provide periodic review of Facilities Department documentation and records such as logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.Maintain quality records and inspection reports pertaining to cGMP related equipment and systems such as HEPA filter certifications, air flow hood inspections, etc. Participate in (as group coordinator for Facilities) and obtain results of all quality and regulatory audits.Coordinate training for Facilities personnel on regulatory and quality topics such as proper documentation procedures and the use of QUMAS.Follows current good manufacturing practices (cGMPs).

Oak Hill, New York

Provide quality and compliance support to Operational areas and key functional groups across the site ensuring regulatory, QMS and GMP compliance. Provide a highly visible and ‘hands-on’ profile within all operational and functional areas; act as a champion for quality; liaise with the Operational and functional areas to drive quality behaviors. Act as a quality coach and/or mentor to develop all staff’s capability in respect to Quality; drive the ownership of quality so that it directly impacts the Operational performance and compliance profile. Work actively with Operational and functional areas to improve their risk management capability; support improvements to risk management, including the ongoing review of risks and the use of the RMS system.Provide Operational and functional areas with timely effective feedback on compliance issues.Drive improvements across all operational and functional groups; support the quality/compliance representatives in each area on a daily basis.Review quality-related incidents and lead / co-ordinate investigations into significant incidents that have resulted in non-conforming products or compliance failures, provide guidance on the disposition of non-conforming products.Internal document approval (e.g. batch records, CAPAs, SOPs, change controls).External document approval, as required.Input into, and approval of, commissioning and qualification documents.Creation of monthly reports on performance of key systems.Develop GMP training modules across site and provide training as appropriate; deliver training as required.Review of, and response to, Quality Alerts.Maintain an appropriate level of compliance to GSK’s QMS; review changes to QMS and assess impact to site; drive ‘in place’ and ‘in use’.Participate in & lead the site’s internal audit programs (level 1 and 2).Support preparations for external audits (level 3 and 4).Support investigations and responses to customer complaints.

Oak Hill, New York

Act as liaison for department with various departments. Liaison between department manager, supervisor and cell team members. Ensure optimum utilization of shift labor. Provide leadership and direction to cell. Proactively promote safe working practices. Ensure implementation of department training strategy. Certify associates training. Effective communication with other shifts/areas to ensure all relevant data is passed on. Handle cell performance issues and conflict resolution. Be proactive in developing ideas for improvement. Communicate with line supply team Communicate with other cell and team leaders to schedule breaks and lunches. Ensure compliance by reviewing documentation within assigned cell. Attendance management. Train associates on job duties during changeovers to optimize downtime. Reward and celebrate team success. Manage inventory of finished product/reconciliation of tubes. Support culture change initiatives within the department. Maintain inventory of supplies within cell. Proactively monitor waste within cell. Maintain visual displays of performance and target efficiencies within cell.Use of OE tools when problem solving with cell team members/encourage JDI’s within cell. Ensure 5S program within cell are being followed. Carry out 5S and GMP audits. Completion of incidents reports in a timely manner

Hobart, New York

Initiate investigations into process deviations and equipment failures.Generate complete investigations with both site Triage’s system and Minor Exceptions. Assess quality issues. Partner with production team leaders and supervision to assess and limit the impact of a process deviation by identifying the scope, developing and applying containment action plans. Assure company compliance and adherence to Code of Federal Regulations (FDA) Good Manufacturing Practice (cGMP) Title 21. Food and Drugs Parts 11.210, and 211. Approve initial packaging line set up by performing overpack inspection and CLCMS data entry. Responsible for performing ANSI sampling, AQL testing, collecting of both QA and Stability samples.Perform Quality Audits and report findings and trending, remedy major issues immediately. Generate and complete QA paperwork for packaging production, as well as review said paperwork completed by other staff prior to production on the packaging line.Execute Inspector Qualification testing and grading, and retraining and retesting as needed.Participate as a team member on Kaizen, Green Belt, and 5S projects.Perform backup coverage for Labeling Department as needed. ASQ: Certified Quality Improvement Associate

B.A., Organizational Management

Education record

A.A.S, Criminal Justice