Quality Assurance Document Control

Jason Morrow

**** ***** ****** ***** ********, GA 30088 Phone: 678-***-**** Email: ************@*******.***

Areas of Expertise

Clinical Trials: Management of the set-up process including database design, documentation, corporate communications, management of timelines/deliverables, logistics, kit building and management of customer service.

PC experience: MS Project, Word, PowerPoint, Access, LIMS, LIMS2000, StarLIMS, Adaptiv, TrackWise, ComplianceWire, BPLM, SmartSolve various Learning Management Systems (LMS).

Quality Systems, CAPA, Change Control, Document Control, audits and deviations in FDA, OSHA, EPD, EPA and cGMP regulated environments.

Excellent written and oral communication skills.

Career History

Quality Assurance Associate ISS Intl., for Takeda, Covington, GA 2023- present Quality management of employees conducting GMP cleaning in a pharmaceutical/medical device space. Management of employee training. Auditing of employees’ performance. Writing reports concerning pest control, CAPAs and deviations. Experience in every facet of quality management from project management, employee training, document control, quality inspections, GMP cleaning and pharmaceutical performance/stability.

Quality Assurance Trainer/Safety Associate Remington Medical, Alpharetta, GA 2019-2021 Conducting new employee on-boarding/orientation. Management of employee training documentation both paper and electronic (LMS). Consultations with management regarding employee training to remain in compliance with ISO13485:2016. Providing assistance with implementation of an electronic document control system. Providing assistance regarding updates to process specifications, work instructions, production records, manufacturing work instructions, and associated forms and appendices. Conducting internal audits of the effectiveness of company processes. Providing assistance with FDA audits. Auditing of manufacturing processes, documents, and electronic systems.

Technical Writer/Auditor (contract) Ethicon, Cornelia, GA 2018-2019 Technical writing in accordance with SME expectations. Facilitating employee training via ComplianceWire after updates are completed. Medical device process approval for group and associated manufacturing areas via the Adaptive system. Quality approval of process specifications, manufacturing work instructions, and associated forms and appendices. Conducts meetings weekly with SMEs to ensure progress and meeting timeline expectations. ISO13485:2016 environment. Audits of manufacturing processes, documents, and electronic systems.

Quality Assurance Associate (contract) CDC, Atlanta, GA 2016-2017 Document Control, employee training (LMS), and medical device process approval for group and associated laboratories via the SmartSolve system. Quality approval of production documents. Coordinates efforts with Quality Management team to ensure implementation of Quality Systems. CAPA, Change Control, and exceptions. Verification of quality logs/data. Assists Quality Manager in servicing quality needs.

Document Control (contract) Shire, Social Circle, GA 2015-2016

Issuing official corporate SOPs, forms via BPLM system (LMS). Management of employee training via ISOtrain. Writing SOPs to define Baxalta documentation process. Coordination of workflow between departments for maximum efficiency.

Project Manager Quintiles, Marietta, GA 2012-2014

Management of initial set-up for clinical trials. Duties include database design, documentation of study progress, kit orders, data imports, result transmission and specimen processing. Open communication with sponsor requests for changes to meet expectations. Following FDA, OSHA, and global standards to ensure safety of the study for participants. Creation of study documents in accordance with company, FDA, and OSHA regulations. Experienced in global projects. Communications and coordination of services in the U.S., Asia, and Europe.

Quality Control Technician (contract) Facet Industries, McDonough, GA 2011-2012

Quality inspections of medical devices in a manufacturing setting. Communication with manufacturing department concerning product quality. Issuing labels and other controlled documents to the manufacturing department. Inspection of incoming materials. Release of medical devices for shipping. Demonstrated proper procedures in deviations during production to ensure patient/consumer safety and FDA, OSHA, and cGMP compliance.

Laboratory Technician DeKalb County Government, Decatur, GA 2007-2010

Wet chemistry techniques including extractions, titrations, column separation and dilutions. Aerobic and anaerobic bacterial colony plating/counts. Media preparation. Maintenance and troubleshooting of technical equipment. LIMS data entry. Review of monthly productivity reports. Usage of technical equipment including spectrophotometers, evaporators, GC, microscopes, and AQ2 analyzers. Proper handling, storage and disposal of hazardous material. Accurate recording of data. Routine lab cleaning. Highly efficient productivity.

Case Coordinator QTC Management Inc., Atlanta, GA 2006-2007

Processing veterans’ disability claims in a team-based environment. Creation of medical exam forms used by physicians to assess veterans’ disability. Obtaining core lab results and x-rays in regard to patient disability. Communication with doctors, hospitals, and other medical facilities. Creation of files, both physical and electronic. Data entry. Excellent medical terminology. Continually met productivity goals.

Records Researcher (contract) ChoicePoint Inc., Duluth, GA 2005-2006

Conducting criminal background checks per employer request. Interface with federal and state databases. Creation of files, both physical and electronic. Professional handling of confidential information. Continually met productivity goals.

Research Assistant Clark Atlanta University, Atlanta, GA 2003-2005

Cultivation of prostate cancer cell lines LnCap, DU145, and PC3. Media preparation. Cell counts. Western Blot, RT-PCR, HPLC, and cell imaging. Proper handling, storage, and disposal of hazardous material including radioactive waste. Accurate record-keeping. Excellent sterile technique.

Manufacturing Specialist Visible Genetics, Suwanee, GA 2001-2003

Manufacturing HIV and HCV tests. Creation of SOPs used in device manufacturing process. RT-PCR. Wet chemistry techniques using Taq polymerase, dNTPs, buffers and media preparation. Ordering supplies used in manufacturing/clean-room environment in accordance with monthly budget. Excellent vendor relationships. Programming Beckman automated robots used in manufacturing process. Usage of industrial scale ovens, washers, and freezers. Accurate record keeping and data entry. Continually met company productivity goals. Proper handling, storage and disposal of hazardous material. Lab/Manufacturing Department Safety Officer.

Education

Bachelor of Science in Biology 1996

Xavier University of Louisiana

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