Consistently achieve diverse documentation goals in a fast paced medical device environment. ► MANUFACTURING: Work with Engineering and SMEs to create and revise standard operating procedures (SOPs), bill of materials (BOMs), production routers, raw material, intermediate, and finished goods specifications, and manufacturing forms. Train staff on document revision, packet preparation, and routing of engineering change orders (ECOs).► PACKAGING AND QUALITY: Work with Marketing,… Show more Consistently achieve diverse documentation goals in a fast paced medical device environment. ► MANUFACTURING: Work with Engineering and SMEs to create and revise standard operating procedures (SOPs), bill of materials (BOMs), production routers, raw material, intermediate, and finished goods specifications, and manufacturing forms. Train staff on document revision, packet preparation, and routing of engineering change orders (ECOs).► PACKAGING AND QUALITY: Work with Marketing, Quality, and Regulatory to create and revise labeling art and specifications, Device Master Records (DMRs), Device History Files (DHFs), Instructions for Use (IFUs), User Manuals (UMs), and Safety Data Sheets (SDS). Show less

My responsibilities Included:► Designing and editing procedure instructions, data-capture documents, and training materials ► Writing accurate documents based on process observation, flow charting, and document validation with subject matter experts ► Executing comprehensive impact assessments for proposed process, document, and labeling changes► Reviewing document and labeling components for consistency, compliance to style guide constraints, and adherence… Show more My responsibilities Included:► Designing and editing procedure instructions, data-capture documents, and training materials ► Writing accurate documents based on process observation, flow charting, and document validation with subject matter experts ► Executing comprehensive impact assessments for proposed process, document, and labeling changes► Reviewing document and labeling components for consistency, compliance to style guide constraints, and adherence to document management requirements► Formatting documents to aid accessibility, usability, readability, and compliance► Expertise employing a variety of document software and computer resources for revising, routing, and tracking according to document control requirements► Creating, organizing, and maintaining archives for value added content discovery ► Working cooperatively with project participants and prioritizing document activities according to organizational goals while anticipating how actions impact other departments ► Responding with flexibility to shifting priorities and rapid change and attaining exceptional follow up results Show less

My responsibilities Included:► Reviewing and approving commercial batch records for extended release oral tablets while examining for compliance to Code of Federal Regulations and internal company written procedures ► Verifying complex arithmetic calculations related to statistical sampling plans, in-process performance measurements, equipment process settings, and final production yields► Tracking critical in-process data for value-added trend analysis ►… Show more My responsibilities Included:► Reviewing and approving commercial batch records for extended release oral tablets while examining for compliance to Code of Federal Regulations and internal company written procedures ► Verifying complex arithmetic calculations related to statistical sampling plans, in-process performance measurements, equipment process settings, and final production yields► Tracking critical in-process data for value-added trend analysis ► Utilizing organizational skills related to document management, review, correction, and completion ► Reviewing, editing and approving of controlled master documents ► Preparing and approving Certificates of Manufacture and related client documentation with meticulous attention to detail► Championing quality and documentation issues through extensive cooperation and resourcefulness with the Production, Planning, and other Quality units to resolve deficiencies and ensure product shipped within critical deadlines ► Appraising management of any significant or unresolved quality related issues ► Providing advice on the development and administration of the company's quality assurance program ► Maintaining extensive manufacturing documentation historical files and archiving according to organizational requirements Show less

My responsibilities Included:► Coordinating and supervising activities associated with Annual Product Reviews, entailing annual reevaluations of quality standards, product specifications, and manufacturing and control procedures for both transdermal and extended release oral tablets ► Verifying that review systems are consistent, comprehensive, and complete ► Maintaining the department schedule while ensuring that projects reach completion in a timely manner ►… Show more My responsibilities Included:► Coordinating and supervising activities associated with Annual Product Reviews, entailing annual reevaluations of quality standards, product specifications, and manufacturing and control procedures for both transdermal and extended release oral tablets ► Verifying that review systems are consistent, comprehensive, and complete ► Maintaining the department schedule while ensuring that projects reach completion in a timely manner ► Developing and maintaining area historical files, consisting of various electronic and paper records management systems ► Organizing, proofreading, analyzing, and distributing a wide variety of data, ranging from document and equipment changes to customer complaints and returned goods ► Designing innovative methods to format summarized data into value-added charts and graphics ► Condensing technical text into concise yet informative language ► Exercising expertise in Microsoft Office and a variety of in-house databases ► Developing intradepartmental cooperation at all levels of the organization ► Informing management both in written and oral formats concerning conclusions drawn from Annual Review data, including trends and problem areas requiring action ► Interacting with clients to negotiate special requests and investigate Annual Review related inquiries ► Responsibility as Annual Product Review Supervisor from March of 1999 through May of 2000 Show less

My responsibilities Included:► Conducting line audits and line clearance for commercial, clinical, and validation process operations and facilities and enforcing cGMP and SOP compliance in production areas and overall facility ► Reviewing in-process testing and sampling results and providing clarification of operating procedures on the production floor ► Initiating, reviewing, and approving departures from established operating procedures; investigating compliance… Show more My responsibilities Included:► Conducting line audits and line clearance for commercial, clinical, and validation process operations and facilities and enforcing cGMP and SOP compliance in production areas and overall facility ► Reviewing in-process testing and sampling results and providing clarification of operating procedures on the production floor ► Initiating, reviewing, and approving departures from established operating procedures; investigating compliance failures, determining impact on product quality, and deciding appropriate responses; and monitoring corrective actions for effectiveness ► Performing commercial product expiration dating, request for commercial product samples, and representing QA Management on working weekends as Person-In-Plant ► Interacting and coordinating with all levels of manufacturing and various department managers to obtain quality results ► Recruiting, hiring, training, and supervising junior members of the department as Supervisor from February through December of 1996 Show less

Responsibilities included:► Coordinating QA and QC activities for batch record review and approval► Representing site QA to customers regarding quality issues and customer audits► Conducting weekly audits for facility compliance with cGMP regulations► Reviewing, trending, and analyzing quality related information► Developing and writing standard operating procedures, master batch records, and specifications for both raw materials and finished… Show more Responsibilities included:► Coordinating QA and QC activities for batch record review and approval► Representing site QA to customers regarding quality issues and customer audits► Conducting weekly audits for facility compliance with cGMP regulations► Reviewing, trending, and analyzing quality related information► Developing and writing standard operating procedures, master batch records, and specifications for both raw materials and finished products► Performing calibrations of production equipment► Providing environmental monitoring of aseptic manufacturing areas and general facilities► Receiving, testing, and disposition of raw materials► Handling returned goods complaints and related incident investigations► Providing training in QA and QC procedures to junior staff Show less

Responsibilities included:► Maintenance of mammalian and insect cell lines► Growth promotion and cytotoxicity testing► LAL gel clot endotoxin testing► Sterility and bioburden testing on both cell media and animal byproducts► Raw material identification utilizing IR Spectrophotometer► Moisture analysis with Karl Fisher machine► Accomplishing a variety of responsibilities in laminar flow hood environments► Performing all in-house… Show more Responsibilities included:► Maintenance of mammalian and insect cell lines► Growth promotion and cytotoxicity testing► LAL gel clot endotoxin testing► Sterility and bioburden testing on both cell media and animal byproducts► Raw material identification utilizing IR Spectrophotometer► Moisture analysis with Karl Fisher machine► Accomplishing a variety of responsibilities in laminar flow hood environments► Performing all in-house testing and maintenance of Reverse Osmosis purified water system► Maintaining lab equipment throughout QC lab► Sterilizing lab equipment in dry heat oven and biohazardous materials in autoclave► Environmental monitoring of aseptic filing areas and hoods► Maintaining lab supply stock and reviewing and filing purchase orders► Training technicians in all of the above procedures Show less

Responsibilities included:► Setting up and monitoring liquid filtration systems► Formulating assorted media and reagents► Aseptic filling of both free standing bottles and bag manifolds► On line testing to ensure batch conformity to specifications► Executing laboratory clean up procedures and the proper handling and disposing of hazardous materials► Conducting line audits for manufacturing operations and facilities► Interpreting and… Show more Responsibilities included:► Setting up and monitoring liquid filtration systems► Formulating assorted media and reagents► Aseptic filling of both free standing bottles and bag manifolds► On line testing to ensure batch conformity to specifications► Executing laboratory clean up procedures and the proper handling and disposing of hazardous materials► Conducting line audits for manufacturing operations and facilities► Interpreting and enforcing complex written procedures for production personnel while maintaining good relations between departments► Safely operating a forklift Show less