Integral part of the Engineering-Facilities team tasked with maintaining the department’s quality systems, standard operating procedures and policies. Additional responsibilities include:Accomplishments • Managing Engineering Drawings and records retention.• Creating automated GMP walk-down procedure and checklist.• Steering Work Order system governing the emergency and preventive maintenance of all critical assets associated with manufacturing operations.• Developing and revising department’s Standard Operating Procedures.• Authoring all department Change Controls, CAPAs and Quality Incidents.• Working with Regulatory Affairs, Validation, Quality Assurance, Quality Control, Manufacturing and Process Development departments to ensure the compliant operation and production of critical equipment and systems relating to all cGMP activities and production of commercial product.

Facilities team member with the unique task of maintaining Merrimack’s quality systems and documentation infrastructure in a compliant state. Accomplishments• Overseeing Work Order Management system governing emergency and preventive maintenance of critical assets associated with themanufacturing process.• Managing company’s badge access security system (Avigilon Red Cloud, Lenel Pro).• Creating and revising all department’s Standard Operating Procedures, policies and training cirriculum.• Authoring department Change Controls, CAPAs and Quality Incidents.• Working with Regulatory Affairs, Validation, Quality Assurance, Quality Control, Manufacturing and Process Development departments to ensure the compliant operation and production of critical equipment and systems relating to all cGMP activities and production in support of commercial product.• Monitoring company’s building management system, troubleshooting issues as they arise.• CFR 21, Part 11.

Responsible for the coordinating, editing, revising and standardizing Supply Chain documentation, including Standard Operating Procedures (SOPs), project plans, policies and technical manuals. Lead writer and investigator for all associated Deviations, Change Controls and CAPAs. Additional responsibilities include proofreading and editing all materials written and submitted by Supply Chain Department personnel.

Held various positions beginning as sports reporter/weekend sports editor. Promoted to daily sports editor and eventually assistant managing editor. Duties included covering and writing articles that fell within coverage area and beat; assigning stories; laying out and designing sports and news sections; editing articles for publication on deadline.