Ryan Heape Email & Phone Number

Indianapolis, In, Us

Indianapolis, Indiana, United States

Bloomington, Indiana, United States

Ensure quality assurance on a strategic level to maintain compliance with ISO 13485.  Review and approve relevant quality system documents Review and approve change requests Review and approve quality records e.g. qualification and validation documents Ensure an appropriate audit program is implemented and maintained Oriel STAT A MATRIX Exemplar Global Certified Qualified Lead Auditor: ISO 9001:2015, inclusive of ISO13485:2016.  Lead the front room and manage the back room with requests of regulatory authorities during inspections and inspections of contract service providers Ensure that developed procedures and specifications are appropriate and followed, including those used by firms under contract to the manufacturer Identify and/or assist in the resolution of potential or existing quality issues that may jeopardize cGXP compliance or regulatory position Review and determine the acceptability of non-conformances and proposed corrective and preventive action plans for product Training of new personnel in both general and specific QA processes Participate in assessing the effectiveness of the quality management system as well as process performance and product quality Ensure continual improvement Ensure risk management procedures are in place Maintain company quality and safety standards

Indianapolis, Indiana, United States

Ensure quality assurance on a strategic level to maintain compliance with ISO 9001, including business development. Assume overall responsibility for Quality Assurance and Quality Control teams and ensure that resource and training requirements are met. Review and approve relevant quality system documentation such as change controls, CAPAs, change requests, qualification protocols, validation protocols, deviations, and product specifications.  Sets objectives to align with broader organizational goals, and breaks down the objectives into appropriate initiatives and milestones. Responsible for assessing the effectiveness and continual improvement of the Quality Management System as well as process performance and product quality. Assist in the coordination and compliance with requests of regulatory authorities during inspections and inspections of contract service providers. Ensure Risk Management and Audit programs are implemented and effective. Identify and assist in the resolution of potential or existing quality issues that may jeopardize cGXP compliance or regulatory position. Ensure that developed procedures and specifications are appropriate and followed, including those used by firms under contract to the manufacturer.  Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories. Responsible for Quality Management Review and the reporting/trending of quality metrics.

Bloomington, Indiana, United States

 Manage and monitor quality assurance systems, processes and facilities by ensuring regulatory compliance in the manufacture of mammalian cell culture products. Manage and monitor training program by ensuring training requirements for employees align with established training curricula and support job descriptions. Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories relating to raw material, in-process and product release. Manage and monitor final batch disposition of manufactured products. Participate in investigations and corrective action identification and implementation process for OOS, OOT and Exceptions. Manage review of various validation and technical documents to comply with regulatory requirements. Manage and monitor on-time closure of corrective action/preventive action items. Implement GMP training program for company employees, in collaboration with the Training department. Manage the activities of direct reports in the conduct of their duties. Maintain trending program for quality metrics including CAPA and PPQE. Facilitate periodic Quality Management Review (QMR) meetings.

Bloomington, Indiana, United States

 Manage and monitor quality assurance systems, processes and facilities by ensuring regulatory compliance in the manufacture of medical device. Manage and monitor training program by ensuring training requirements for employees align with established training curricula and support job descriptions. Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories relating to raw material, in-process and product release. Manage and monitor final batch disposition of manufactured products. Participate in investigations and corrective action identification and implementation process for OOS, OOT and Exceptions. Manage review of various validation and technical documents to comply with regulatory requirements.

Bloomington, Indiana, United States

 Review documentation for accuracy and compliance to procedures. Maintain quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products. Review and approve SOPs, change management requests and change controls for quality impact and compliance. Review and approve item masters and product specifications. Perform technical and administrative review of batch and analytical data for accuracy and compliance to procedures for raw material, in-process, and product release. Review and approve QC product testing documentation supporting batch release. Perform and manage exception report, corrective and preventive action, and batch record review. Review and approve level II exception reports. Perform and document CAPA effectiveness checks. Participate in internal and external audits. Track and trend quality metrics, CAPA, PPQE.

Indianapolis, Indiana, United States

 Log test results, complete lab submission forms, post requests to contractor site, and forward request to third party labs.  Complete results entry step in AdminLIMS for physical, dimensional, and analytical results. Compile lot data package, provide initial technical review of data, and collaborate with GPTD final reviewer/verifier. Change Initiator and Executer for change controls in the Trackwise system and Lead Investigator with Root Cause Analysis training for any events. Technical contact for GPTD engineers for specification migration from Penguin to Regulus.  Key technical contact between GPTD and incoming QC labs for packaging components.  Support packaging-related data management and GPTD laboratory initiatives as necessary.

Terre Haute, Indiana, United States

 Management and oversight of Quality Assurance – Exubera Device Packaging Operations for GLP, GMP, FDA and ISO 13485 compliance. Acted as final release authority of all incoming and finished good lots of Exubera Inhalers, Chambers, and Insulin Release Units. Served as the main contact in Quality Assurance within Terre Haute operations and with our contract manufacturers and clinical operations. Exubera Product Complaint Investigations. Authored and revised numerous SOPs, Protocols, Quality Agreements, and Quality Action Reports with Corrective and Preventive Actions. Production Order and Batch Record Review and Approval. Participated in FDA and ISO audits as subject matter expert for Quality. Performed various duties on lot management systems (AS400, MAPS, LRS, LIMS, RCS) such as initiating and coordinating testing of all the medical devices, data verification, stage approval, and status disposition.

Chemistry, Chemistry

Doctor Of Law - Jd, Law

Bachelor Of Science - Bs, Public Affairs

Bachelor Of Science - Bs, Physician Assistant