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 compliance teamResponsibilities include:• 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• Provide Project Management support for special projects• Ensuring F&E personnel training is optimal and remains in a cGMP compliant state• Manage, mentor, and develop the compliance specialists• Manage Document Change Request tasks in a timely manner • Assist with Deviation management reviews when necessary• Identify opportunities to improve F&E processes an practices to increase our compliance readiness• Comply with requirements from the company’s safety program including health and safety regulations and OSHA requirements

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• Develop and manage the overall department monthly report for senior leadership• Coordinate monthly energy tracking (Electricity, Gas, Water, Wastewater) and trending for budgeting and energy savings improvement projects• Oversee small to medium sized projects for the Facilities and Engineering Department as assigned by managementDeveloped and Managed a Training program for a Web Based Meeting Platform allowing for over $500K yearly saving in travel and “lost field time” and aided in a significant difference in communication and decision making timeframes.Some Projects worked on in this 16 months include: *Manufacturing Facility Build - design processes to gather necessary data to populate the Management System Databases as they pertain to Assets and Instruments. *Develop a process to track and drive the health of the department's quality system to GOAL.*A complete department Learning Plan review to eliminate unnecessary training from curricula and align the proper curricula to the postions throughout the organization.* A member of the Employee Engagement Survey Committee to improve the commuications of the site.*Manage Resource Conservation Steering Team

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, then deploying to a project team that generally consists of a Core Team (Brand Marketing, Sales Training, field force Associate Directors, Sales Meeting & Planning, and OCG). Facilitate brand/training sub team meetings by identifying and promoting functional timelines and coordinating the work stream of deliverables. This process provides the stakeholders a forum to communicate and collaboratively work with PMRC submissions and tactics. This ensures the production of materials meet disk release deadlines necessary to reach project goals and provide for the flawless execution of major sales meetings. Separately, I provide Web based meeting support for the Marketing, Sales Training, and Field Sales Force teams. In my tenure I have developed a training program for administrative support allowing them to manage the Web platform for their groups with smaller scale meeting needs.

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 action problem solving techniques; scheduling and monitoring internal audits; served as acting plant contact for all external audits; planned and conducted required meetings advising upper management of quality system progress and or problems; and utilized MILSPEC form of sampling for quality control. As the Environmental Coordinator I received training from Lion Technologies on Federal and State Regulations regarding the handling of hazardous materials and toxic waste within the plant along with transporting them off site, training from the EPA on toxic release inventory reporting, and training from Mass DEP on TURA reporting. I was the plant contact for all visits from federal, state, and corporate external audits, along with the plant administrator of the Stormwater Pollution Prevention Plan and the Plant Wastewater permit.

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