John Saldibar Email & Phone Number

San Diego, California, United States

 Supports both clinical and commercial autologous cell therapy manufacturing at the Bothell, WA manufacturing site by closing deviation by original due date. Actively manage deviations to achieve RFT (right first time) and on-time phase completion. Partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA. Assess trend details to ensure accuracy and alignment across the team. Participate in various project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Facilitate in-depth root cause analysis to determine additional process and system failure modes. Lead GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations. Apply multiple RCA tools to deviation investigations. Author, and review deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence using Enterprise Quality Assurance & Regulatory Affairs Management System Veeva.

Bothell, Washington, United States

 Supports both clinical and commercial autologous cell therapy manufacturing at the Bothell, WA manufacturing site by closing deviation by original due date. Actively manage deviations to achieve RFT (right first time) and on-time phase completion. Partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA. Assess trend details to ensure accuracy and alignment across the team. Participate in various project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Facilitate in-depth root cause analysis to determine additional process and system failure modes. Lead GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations. Apply multiple RCA tools to deviation investigations. Author, and review deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence using Enterprise Quality Assurance & Regulatory Affairs Management System (eQRMS) and Infinity.

Cleveland, Ohio, United States

 Initiate, plan and drive the changes and processes that support building a company’s quality system. Provide guidance and advice to employees across the Quality and broader Athersys organization on matters related to the QMS. Establish and educate on process for Change Controls, while participating in Change Control Review. Write, review, and manage SOPs, deviations, CAPA and OOS using Ensur. Perform and assist with, internal/external audits for compliance with GMP/GCP activities and process. Review and provide feedback on regulatory submissions. Write, review, and improve quality system documentation. Assist with new employee training for compliance with GDP/GMP/GCP.

St Petersburg, Florida, United States

 Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production. Investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities. Author, review and approve technical documents, such as: Technical Protocols and Reports, Process Validation Protocols and Reports, Cleaning Validation Protocols and Reports, IQ/OQ/PQ Protocols and Reports, SOPs and, Change Control, as it pertains to the above validated/qualified systems. Author, Review and approve deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence. Serve on site project teams. Interface with Engineering, Validation and Manufacturing management on capital projects and proactively ensures cGMP compliance, business conformance and technical validity for the design, construction, validation and start-up process life cycle of each project. Assist in the implementation of QA policies and procedures Ensure that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress. Assist with cross-departmental assignments and or approvals, according to departmental needs. Primary quality liaison for clients and internal customers and the Subject Matter Expert for the client products, processes and requirements. Maintain, develop, and nurture the client partnership to ensure alignment and consensus. Coordinate functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks. Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems.

Myerstown, Pennsylvania, United States

QA IV Documentation Scientist (2008 – 2019), QA III Method Development Scientist (2008-2012) / Stability Chemist (2000-2008) Author, Review and approve deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence. Evaluate review and release batches for mixing, compression, coating, packaging, and finish goods ensuring good manufacturing practices (CGMP) and Bayer specifications are met. Interact with appropriate personnel to ensure that products, line trials, and special projects are manufactured/packaged/shipped to established specifications and meet market objectives.Performed verification, validation and method transfers of processes utilizing problem solving skills, job knowledge and computer/technical skills. Trained chemists on methods that were newly developed. Performed standard qualitative and quantitative analysis and release on Bulk and Stability drug substances in a fast and efficient manner. Performed computer validation in GMP environment with Near-IR. Consistently completed samples before scheduled due date.Utilized standard analytical chemistry techniques including wet analytical methods. Utilized sophisticated electronic instrumentation (HPLC, UV, GC, IR, NIR, AA, Technicon, dissolution apparatus, Karl Fischer, moisture analyzer, TOC, pH meter, and Robot). Gained a working knowledge of organic chemistry, statistics, data processing, and good manufacturing practices. Communicated ideas, concepts, and work results effectively to colleagues and supervisors. Completed special studies and projects, which helped the corporation (leak studies, label component migration studies, crossed-trained in both liquid and solid dose drug). Solved problems independently, consulting supervisors when necessary.

Reading, Pennsylvania, United States

 Planned and implemented daily practice sessions that were instructive and progressive utilizing appropriate safety standards. Placed orders for equipment, uniforms, and supplies needed for the team. Established positive and effective communication with athletics director and all support staff. Provided counseling and advice to student-athletes concerning academics and performance. Submitted and monitored proposed budget. Supervised, organized and monitored all fund-raising activities. Assisted in grant proposals.

Scranton, Pennsylvania, United States

 Conducted the daily work of Dental Specialist by maintaining cleanliness of all tools, quality ofpaper/electronic records and set-up of equipment at the work site. Completed a primary leadership course resulting in a promotion to Sergeant. Trained, assisted, and lead incoming soldiers to enhance performance on and off the field. The only soldier in the unit who completed a combat life saving course. Administered medications intravenously into patients when medics were not available. Received the Army Achievement Medal for service as the NBC (Nuclear, Biological, Chemical) Specialist. Assisted recruiters by traveling to colleges and High Schools within the state of Pennsylvania. Performed tasks under pressure in an efficient manner at a specified time. Worked as a team and took lead when needed.

Bethlehem, Pennsylvania, United States

 Utilized analytical chemistry techniques and wet analytical techniques. Utilized AA, pH meter, and Furnace to analyze samples. Followed set procedures from Bethlehem Steele and NIST. Performed all analysis and special projects in a timely and efficient manner.

Master Of Science - Ms, Pharmaceutical Sciences

Bachelor Of Science - Bs, Chemistry

Activities and Societies: SGA, Track and Field, Cross Country, Who's Who Among American Universities and Colleges.