Helen Weagle Email & Phone Number

Troy, NY, US

Slingerlands, New York, United States

Slingerlands, New York, United States

Slingerlands, New York, United States

Latham, New York, United States

Latham, New York, United States

Latham, New York, United States

Latham NY

Framingham Biologics

• As a Compliance Manager I am responsible for providing quality support, ensuring all of Facilities and Engineering compliance requirements are completed in a timely manner, and to provide leadership & direction to the.
• Primary contact for all matters related to compliance
• Partner with QA to ensure all Deviations, CAPAs, Change Requests, and Regulatory Commitments are completed to a high standard and in a timely manner
• Interact with QA to support regulatory and internal inspections/audits
• Work cross-functionally within the organization to ensure F&E processes are compliant to internal and external requirements (e.g. Quality System Remediation, Global company initiatives, etc.)
• Responsible for reporting and managing F&E metrics to include ensuring the integrity of the data and provide analytical tools with recommendations for data owners/SMEs to drive business improvements

Framingham Biologics

• Develop mechanism to track and maintain metrics for all department deliverable KPIs
• Support departments with the tracking of resource allocation for department projects and initiatives including contractor tracking
• Support the department budget and expense tracking process
• Primary compliance coordinator for tracking all department Regulatory Inspection Commitments, LCRs, CQAs, Deviations, CAPAs, Plateau Training, and MDRs
• Work with department leaders to develop appropriate measures to track and improve quality event trending
• Establish mechanism to track and maintain all HSE deliverables: CAPAs, PASS Objectives, and related projects

As a Project Manager in the Commercial Operations group my primary objective is to lead project management activities for significant Commercial initiatives across multidisciplinary project teams (e.g. FLT/POAs, Brand Planning, New Hire Training etc). The key activities include developing project process flow while gaining agreement with key stakeholders.

As a manager in training I was responsible daily for cash handling, store totals reporting, customer service, employee relations, and vendor receiving. I also had specific departments assigned to me and was responsible for all merchandising, inventory control, and vendor relations such as how their product is displayed and product rotation/expiration issues.

As the Quality System Manager I was responsible for writing all company policies, procedures, work instructions, and quality forms; to ensure all employee training procedures and records are up to date; inspecting and reporting customer returns utilizing pareto charts; performing root cause investigations from customer complaints including corrective.

Bachelors, Business Administration And Management, General

Certificate, Fundamentals Of Biomanufacturing

Project Management Certificate

Bachelor Of Business Administration - Bba, Business Administration And Management, General

Bachelor Of Business Administration - Bba, Business Administration And Management, General

Bachelor Of Business Administration - Bba, Business Administration And Management, General

Bachelor Of Business Administration - Bba, Business Administration And Management, General

Associates Degree In Science, Business Administration