Constance S. Email & Phone Number

I have a Bachelor of Science Degree with 17 years of experience in a cGMP/FDA controlled regulated enviornment with 5 years of Supervisory experience with direct reports. I have first -hand knowledge of Drug Manufacturing, Qualiy assurance and Regulatory compliance. I also have technical writing ability and verbal communication skills as well as, the ability to assist with deviations and quality investigation.• Ensure that the teams complies with cGMP and HACCP guidelines to ensure food safety, food quality and customer specification. • Ensures that all packaging goals are met by ensuring that the packaging lines has the necessary staff and materials required to achieve daily goals.• Ability to effectively supervise a team of approximately 50 team members.• Assist in deviations investigations reports, prepare paperwork and submit samples to the quality control and stability department for microbiology. • Supervise operators on a daily basis, conduct checks on documents, and take corrective actions to prevent deviation.• Ensure target production numbers are met on a daily basis and cGMP, documents are completed in a timely manner.• Effectively handles all emergencies and reports incidents to appropriate personnel. Investigates immediately and utilizes support services (HR, Safety, Quality•Provide feedback, coaching and cross training to manufacturing staff to develop a highly skilled workforce with potential for promotions.• Wear appropriate PPE and ensure line workers are wearing appropriate PPE as stated in the GMPs.• Completes all reports, root cause analysis, corrective actions, and work with Engineering, Maintenance, and Continuous Improvement to resolve any equipment inefficiencies,Report and document accidents and incidents immediately by following proper procedures.Monitor the Production process to make sure that it stay on schedules and correct any problems that may arise.