Mary Beth Gatchell Email & Phone Number

Elizabethtown, Pa, Us

Fort Washington, Pennsylvania, United States

Fort Washington, Pennsylvania, United States

 Role Description: Responsible for day-to-day supervision of compliance functions and cGMP compliance practices. Areas of focus include site supplier quality, inspection readiness, product quality complaints system, and retain sample management.  Major Duties Include: Actively partner with stakeholders, individuals, teams and external suppliers to implement innovative solutions and continuous improvements with demonstrated and measurable business results. Coordinate timely completion of site investigations related to raw material/component quality, compliance and supplier performance gaps and deficiencies.  Coordinate service provider quality related activities. Assist in the development and execution of quality agreements. Oversee Retain Management program. Oversee the Product Quality Complaints process for the Fort Washington plant. Review and approve documentation related to complaints and retains. Provide support as member of site inspection readiness team. Responsible to prepare for, coordinate and host external audits (including FDA) for the site.  Performance Management and Development of Direct Reports including training, coaching and mentoring, goal setting and performance evaluation.

Lancaster, Pennsylvania Area

 Responsible for managing all service providers and site specific raw material/component suppliers for the Lancaster site. Work with site Quality, Operations, Procurement, and Suppliers/Service Providers to ensure supplier quality and performance. Assist in other compliance related responsibilities including inspection readiness and internal auditing.  Primary responsibilities include the successful deployment of the McNeil SQM strategy and implementation of associated policies, procedures, programs, and initiatives at the McNeil manufacturing site level. Implement solutions and continuous improvements with demonstrated and measurable results.  Coordinates timely completion of site investigations related to raw material/component quality, compliance, and performance gaps and deficiencies.  Assists in the development of raw material/component specification and associated supplier quality and service expectations. Assists in the development and execution of quality agreements and supplemental schedules. Assists in the alignment of supplier specifications/expectations to McNeil incoming, in process, and final product specifications, procedures, and policies. Assists in the on-going quality/compliance and service performance of suppliers by coordinating the timely and accurate collection and reporting of site-level data. Actively works with and leverages the activities of various site functional groups for the continuous improvement of component quality and performance. Assists and actively participates in the alignment and monitoring of the on-going quality, compliance and service performance of contracted services. Assist in preparation, coordination and hosting of internal audits for the site. Review audit findings, responses and ensure corrective/preventative actions have been taken and are effective. Supports site during regulatory inspections; presents as Subject Matter Expert.

Lancaster, Pennsylvania Area

 Role Description: Provide daily direction, planning and compliance focus consistent with the Supply Chain’s goals, while meeting the compliance goals of Quality Assurance. Provide compliance perspective and expertise to ensure that the process consistently meets all internal and regulatory standards. Major Duties Include: Provide real-time compliance consulting and expertise to the site Act as signatory on compliance documentation including Quality Notifications (investigations), Change Controls, Standard Operating Procedures (SOPs), Master Batch Records and SAP PM Calibration and Work Order data Provide training and direction to direct reports. Provide guidance on setting objectives, frequent feedback and timely performance reviews

Lancaster, Pennsylvania Area

 Responsible for providing daily Quality Assurance support to the Operations area. Provide real time consulting with regard to both quality and compliance functions. Major Duties Include: On line Quality support for batch record review, logbook review, component verification, line clearance and preventive maintenance review Responsible for compliance review of completed batch records including Solids Manufacturing and Packaging Responsible for review/release of components and internal bulk for packaging Responsible for managing quarantined material inventory Support efforts for tactical compliance improvements Support the completion of Quality Notification Investigations Provide Construction Protocol approval Ensure shift coverage for production support is in place

The Value Stream Manager leads and integrates the efforts of operating teams across multiple shifts to insure that quality products are safely manufactured in sanitary conditions. The Value Stream Manager is responsible for efficiently and effectively managing the area within cost goals and produce sufficient quantities to meet customer demands with engaged associates. The Value Stream Manager will also provide leadership and motivation on Strategy, IBO’s, the Operating System, and Associate Development:Directly and indirectly manage a cross-functional team in the overall operation of the value stream, including Activity Management, Capacity Planning, Machine rates, Maintenance and Engineering projects, Research and Development improvements, and SchedulingProactively manage associate relations issues; guide and direct the hiring, training, retraining, development and motivation of Operations associates following team working principles. Drive Associate engagement through a foundation of teamwork and individual accountabilityAssure the ongoing production of safe and defect free products as well as demonstrated proficiency in HACCP. Own on-going training and championing of quality goals and improvements at the area levelUtilizing Operations teams establish area performance standards and goals based on site goals and strategies; measure, control, take corrective action and report results as appropriate in all areas of responsibility. Annually assist in development of area budgets and KPI targetsManage/guide the technical area coverage resources for the troubleshooting and repair of process/packaging equipment problems, with the objective of effectively utilizing these resources to achieve desired performance levelsEnsure that open communications are established and that opportunities to broaden the scope and responsibility of Operations teams/associates are undertaken. The Area Manager is the key resource to deliver regular business performance updates

 Execute the production plan. This consists of: Firming schedule with the Planning Department; Working with the Operators to monitor the level of components and supplies; and working with other department Team Leaders and Operators to overcome daily operational issues within the packaging department.  Maintain high quality standards of the department's products by enforcing and/or updating applicable GMP’s and SOP’s. Ensure compliance with cGMP’s and Standard Operating Procedures.  Oversee performance of wage personnel in the Solids Manufacturing, Packaging, and Liquids Departments. Provide formal performance appraisals biannually and performance feedback as needed. Direct, train, motivate, and evaluate assigned employees in compliance with HR policies.  Adhere to all safety policies, procedures, and regulations, and assure similar compliance among direct reports.  Approve Solids and Liquids Standard Operating Procedures and Batch Records.  Participate in daily PRT walk-throughs as well as attend weekly PRT meetings. Assist with metrics reporting as needed.  Investigate Compliance Events: Write Events and develop and follow through with Preventive Actions  Function as Operations SAP QN Power User. Participated in the integration testing prior to SAP QN go-live in August 2005. Also assisted with training of new SAP QN users.

 Reviewed Solids and Liquids Batch Records in order to ensure batch record accuracy and completeness prior to product release.  SAP Quality Power User: Provided support for SAP Core Team during the SAP upgrade during 2002 and 2003. Responsible for training all new SAP Quality End Users and providing on-going assistance with SAP issues.  Participated in the investigation of Non-Conformances. Responsible for writing non-conformances and developing and following through with Corrective Actions. Performed SOP revisions due to Corrective Actions or to reflect current processes. Ensured that non-conforming materials were unavailable for use via movement of materials through SAP and the physical tagging of blocked materials.  Assisted the Quality Facilitators in the approval of Master Packaging Records Provided New Hire Orientation cGMP/Quality Training. Additionally, have coordinated and provided cGMP training to Operations groups in the plant. Assisted in the design and presentation of plant-wide FDA Readiness Training. Assisted Quality Facilitators in FDA Readiness activities. Member of project team to Eliminate Manual Label Reconciliation Additional duties included the verification of Bills of Material used for issuing components to a packaging lot, performing Imodium potency calculations, the maintenance of the SOP cabinet for the QA department, and the review of Raw Material Reconciliation forms. Inspection and release of incoming packaging components

Master'S Degree (In Progress), Regulatory Affairs And Quality Assurance

Bachelor Of Science (Bs), Biology / Allied Health

Activities and Societies: Beta Beta Beta -- Biological Honor Society