John K Boone Email & Phone Number

Sacramento, California Area

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.

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.

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.

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.

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 ►.

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.

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 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►.