• Excellent written, communication, organizational, and leadership skills. Able to provide assistance and motivation via mentoring, coaching, and motivation.• Certified departmental Quality trainer. Demonstrate key leadership through effective standard and work practices.• Strong analytical and problem solving skills.• Contributes to ongoing training programs for the purpose of maintaining departmental compliance.• Oversee/performs batch record reviews and closures, SOP’s reviews, and exception reports to identify deviations and non-compliance.• Oversee/performs rejection/termination of lots.• Oversee final product packing and distribution.• Ensures timely release of raw materials from the warehouse for production.• Performs Quality on the Floor inspection of modules.• Serves as interdepartmental liaison to promote quality culture.• Serves as a point of contact for information regarding quality evaluation and goal setting.• Strong interpersonal / communication / influencing / negotiation skills• Oversees/Supervises/mentors new trainees to various departmental functions.• Knowledgeable of cGMP's, standards, and procedures.• Ability to lead and influence a team to achieve desired goals.• Represents department in numerous cross-functional teams, projects and GXP-related problem resolution• Performs GMP internal and external audits, and monitors compliance.• Ability to work effectively in a team environment on multiple projects.• Reviews and analyzes data and documentation to identify trends and deviations. • Member of FDA audit team.

 Conducted thorough quality inspections and audits to ensure compliance with established standards, regulations, and protocols. Assisted in the development and implementation of quality control procedures, including testing methods, sampling plans, and inspection criteria. Supported the development and maintenance of quality management systems, including document control, change control, and deviation management. Assisted in the investigation and resolution of quality-related issues, including customer complaints and non-conformance events, using root cause analysis and appropriate corrective actions. Participated in the validation of manufacturing processes, equipment, and analytical methods to ensure their accuracy and reliability. Contributed to the creation and revision of Standard Operating Procedures (SOPs) and work instructions to align with current regulations and industry best practices. Actively participated in continuous improvement initiatives, suggesting and implementing ideas to optimize quality systems and enhance overall quality performance. Assisted in the training of employees on quality procedures, GMP (Good Manufacturing Practices), and other relevant quality standards. Prepared and presented quality metrics and reports to management, highlighting trends, areas for improvement, and compliance status. Conducted risk assessments to identify potential quality risks and implemented mitigation strategies.

 Developed and delivered training programs and workshops to educate employees on laboratory protocols, safety procedures, and equipment operation. Designed and implemented hands-on training sessions to enhance employees' technical skills and proficiency in laboratory techniques. Provided guidance and support to new hires, ensuring their smooth integration into the laboratory environment. Collaborated with management and subject matter experts to identify training needs and develop training materials accordingly. Conducted regular assessments and evaluations to measure the effectiveness of training programs and make necessary improvements. Maintained up-to-date knowledge of industry trends, regulations, and best practices in laboratory procedures and training methodologies. Assisted in the development and implementation of standard operating procedures (SOPs) for laboratory processes and equipment usage. Troubleshoot technical issues and provide timely solutions to ensure the smooth operation of laboratory equipment and systems. Fostered a culture of continuous learning and professional development among employees, promoting a positive and productive work environment. Participated in laboratory audits and inspections, ensuring compliance with regulatory standards and quality control measures.