John Rositch Email and Phone Number

As a Validation Engineer I am responsible for creating IQ/OQ/PQ, packaging validation, and cleaning validation protocols for tablet filling and packaging equipment for over-the-counter and Rx medications in a fast-paced manufacturing environment. In addition I conduct temperature mapping studies of manufacturing and storage facilities, provide input for the purchase of new packaging equipment, and work with the Maintenance and Production Departments to optimize equipment operation and efficiency.

Provide leadership for six Quality Assurance Specialists on three shifts and weekendsResponsible for providing quality oversight of the excipient manufacturing processes Review, approve, and revise GMP documentation for quality and manufacturing operationsConduct internal audits of manufacturing and warehousing operations to ensure GMP complianceIdentify and assess opportunities to improve quality systems and manufacturing processes through data analysisReview and approve deviation investigations and CAPAs for manufacturing and quality control laboratory quality events Provide disposition of raw materials and products based on deviation investigation recommendations with justification through root cause and data analysis. Review and approve change controls for equipment, GMP documentation and manufacturing processesReview and approve equipment IQ/OQ/PQ documents Provide quality metrics to Site Leadership Team and recommend opportunities for improvements

Responsible for the quality assurance oversight of the liquid mix and liquid packaging operations for cough and cold, antacid, and nasal spray OTC productsSupervised and coached four Quality Assurance Technicians and two Quality Assurance Release TechniciansInvestigated quality events including evaluation of SISPQ impact to product, gathering and analyzing evidence, and documenting the findings of the investigationRevised cGMP related procedures as needed to comply with Corrective Action / Preventative Action (CAPA) tasks created through deviation investigationsPlaced raw materials, components, and finished goods material on hold in SAP for containment until the deviation investigation has been completed to determine material disposition

Reviewed and approved deviation investigationsReviewed and approved CAPA tasks initiated through deviation investigationsConducted internal audits of the six FDA quality systems Annual Product Review (APR) document review and approvalApproved instrument calibration specification changesTeam Leader of the foreign matter characterization project to identify and catalog objectionable and non-objectionable foreign matter found in the manufacturing and packaging processes Team Leader of the machine vision system inspection project for identifying the presence of dosing devices in finished goods packaging Reviewed and approved calibration non-conformance investigationsFacilitator of problem solving training for Quality Assurance Auditors Provided risk assessments for manufacturing and packaging quality events Proficient in the use of SAP software for containment of raw materials, components, and finished goods products subject to quality defects and deviation investigations, and for providing justification of release of material meeting all respective quality criteriaFacilitator of the Always Quality Team with the objective of targeting areas of opportunity for quality and process improvementsProficient in the use of Minitab, Microsoft Office, SAP, and Trackwise software

Created cleaning verification procedures for pharmaceutical processing equipment Assessed and made recommendations for the use of appropriate detergent solutions and solvents to effectively remove product residue and foreign matter Experienced in using a boroscope for inspecting equipment for product residue and foreign matter

Supervised eight Quality Control Laboratory Technicians and two Process ChemistsDeveloped and coached Quality Control Laboratory staff through training, setting department goals and objectives, and empowering them to make key decisions based on demonstrated core competencies and job performanceInteracted with internal customers to review product quality on a quarterly basis and report any quality related issues to site Quality and Operations ManagementRoutinely provided updates on the status of product quality to site and upper level corporate Quality and Operations ManagementFacilitator of the site Presidential Quality Initiative Program with the objective of improving right first time metrics Increased the right first time metrics for product batch completion from 10% to 90% through the use of statistical regression analysis Responsible for monitoring ISO compliance Provided technical support for R & D new product development and optimization of current manufacturing processesDeveloped a process for the optimization of the manufacturing automated control system resulting in a 50% reduction in batch cycle timeProficient in the use of Minitab and NWA statistical software