Jill Watkins Email & Phone Number

Philadelphia, Pa, Us

Responsibilities include:Hand Assembly and Quality Departments

• Develop and maintain an organizational structure that effectively supports current and future departmental and corporate directions.• Manage activities within the operations to ensure that production/operational deadlines, project schedules, of all services are met. • Maintain and evolve a best in class marketing service offerings.• Interact with both internal and external clients’ to develop solutions to meet strategic marketing objectives.• Provide project management including budget tracking.• Develop and utilize quality control checklists.• Recommend and implement process improvements.• Attend internal and client meetings as required.• Evaluate employee performance through ongoing feedback and written appraisals, provide goals for continued development.• Plan and coordinate staffing levels and control the allocation of resources.

Lead iniative to new processing platform for inventory system

 Lead Quality Systems improvements at company.  Investigate formal and major customer quality complaints for the company.• Establish validation protocols, and manage validation program. • Conduct/manage periodic internal/external audits, and GMP training activities. • Management of Change Control. • Assist in developing and working within a budget for auditing, training, and compliance activities. • Assist in compliance implementation strategies in all new product development. • Interface with quality certifying bodies.  Responsible for implementation of new requirements and maintained current procedures for ISO documentation for company Designed and executed client product audits and program assessments in the pharmaceutical industry.• Standardized and updated FDA regulated and internal policies and procedures. Responsible for Product Compliance and Accountability processes and systems.

Trenton, Nj

• Develop, manage, and maintain appropriate policies and procedures to ensure regulatory compliance. Establish and maintain key quality indicator elements, organize quality goals and objectives. Identify, assess and incorporate best demonstrated industry practices to assure cGMP and regulatory compliance with all FDA and applicable external US regulatory requirements and applicable guidance documents.• Assure that Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.• Manage and support all FDA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities.• Apply modern principles of quality systems and strategic planning to products and processes to achieve sustainable quality and compliance performance.• Establish and/or improve monitoring measures for key elements related to quality goal attainment. Analyze and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations.• Supervise assigned Quality Assurance associates • Develop and conduct training for QA Associates and production personnel, as necessary. Ensures that QA department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated. • Oversee audits of production, warehouse, maintenance, analytical laboratory, etc.• Recommend continuous improvement plans based on observation of process, vendors, data, etc to management.• Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.

Six Sigma Black Belt Certificate

Program Based - LSSBB studies

Business