Accomplished QA specialist and leader with success playing a key role in the continuous delivery of superior products
Houston, Texas Area
- Past
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- Quality Assurance Officer at Kriger Research Center, Inc
- Quality Assurance Supervisor at SouthWest Environmental Laboratories, Inc.
- Quality Assurance/Quality Control Manager at M.B.A Labs
- Education
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- Kriger Research Center
- University of Houston
- State University of New York College at Oswego
- Recommended
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2 people have recommended Mark B. - Connections
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41
connections
- Industry
- Pharmaceuticals
- Websites
Mark B. Johnston’s Summary
QUALITY ASSURANCE SPECIALIST - Pharmaceutical Product Manufacturing
Accomplished QA specialist and leader with a successful background playing a key role in the incessant delivery of superior products in compliance with regulations and top standards.
• Renowned for focusing on continuous quality improvements, providing team members with the strategies, resources, guidance, support, and motivation to exceed objectives within challenging work environments resulting in increased productivity from team members.
• Cultivate productive relationships with specialists within diverse operational platforms (including laboratory, manufacturing, project planning, quality control testing, packaging / labeling, and quality assurance) producing improved multi-discipline quality.
• Successful in orchestration of audits, peer reviews, corrective / preventive action planning, QC data reviews / analysis, procedures development, staff training (quality control, safety, ethics, etc.), and establishment of SOPs leading to advances in the quality system.
Team Facilitation • Full Project Lifecycles • Collaborative Operational Platforms • Research
Standard Operating Procedures (SOP) Reviews • Raw Material Testing • FDA Regulations
Manufacturing Quality Assurance • Regulatory Compliance • Documentation • Training
Root Cause Analysis • Creation of Specifications • Problem Analysis / Troubleshooting
TCEQ, ISO, and NELAC Accreditations • Certification in cGMP, GCP, GLP (2009)
Mark B. Johnston’s Specialties:
Quality Assurance; auditing, document control, SOPs, training, calibrations, data review, Corrective Actions and Preventive Actions, regulatory compliance
Mark B. Johnston’s Experience
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Quality Assurance Officer
Kriger Research Center, Inc
(Pharmaceuticals industry)
November 2008 — January 2009 (3 months)
Provided audit planning expertise focused on Quality Control Lab records. Tackled this internship project following more than 18-year track record of success providing expert QA management services within laboratory environments.
• Created comprehensive audit report encompassing observations and recommendations for corrective actions.
• Prepared detailed raw material and finished product specification for rhEGF.
• Organized and presented FDA submission requirement details for a generic product.
• Authored Standard Operating Procedure encompassing utilization of an exacting analytical balance.
• Functioned as QA Trainer delivering orientation sessions to staff members, providing details of GMP-compliant pharmaceutical manufacturing platform. -
Quality Assurance Supervisor
SouthWest Environmental Laboratories, Inc.
(Environmental Services industry)
September 2004 — October 2008 (4 years 2 months)
Promoted to monitor QA operations within chemical and microbiology testing laboratories.Coordinated comprehensive quality control tests, leading the expert implementation of 200 techniques.Successfully planned and administered internal audits.Facilitated identification and troubleshooting of quality issues.Increased client satisfaction through cultivation of productive relationships.Secured NELAC Accreditation and TCEQ Certification (encompassing compliance with ISO 9001 regulations). Impacted lab productivity with the creation and revisions of SOPs and root cause analysis strategies.
Met deadlines within challenging work settings through expert planning, scheduling, implementation, and management of resources.Generated annual savings totaling over $1,700 by identifying that there was no need for specific radiation licenses for equipment.Achieved top commendations and award for superior performance / contributions. -
Quality Assurance/Quality Control Manager
M.B.A Labs
(Environmental Services industry)
January 1995 — September 2004 (9 years 9 months)
Spearheaded QA / QC operations within chemical and microbiology testing platform, including creation / revision of over 100 laboratory SOPs, testing efforts that included implementation of 100 methods, and administration of data audits on 1,000s of reports annually. Conducted statistical data analysis, audits, traceability procedures development, Quality and Safety Manual revisions, and permit interpretations. Functioned as Radiation Safety Officer (RSO).
• Ensured high levels of data accuracy within reports, laboratory documentation, and manuals.
• Orchestrated laboratory safety and quality meetings as well as training programs.
• Secured ISO 17025 Accreditations (3 times) and NELAC Accreditation (2 times), achieving successful transition.
• Slashed expenditures through SOP revisions.
• Pioneered creation and provided enforcement of unambiguous traceability procedures.
• Enhanced document management system with the establishment of highly effective control techniques.
• Improved safety and quality manuals.
• Leadership increased laboratory success rate on unknown Proficiency Tests from 81% to 95%.
Mark B. Johnston’s Education
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Kriger Research Center
Certificate , Pharmaceutical Quality Assurance , 2008 — 2009
Received certificate in ICH GCP, GMP, GLP in January 2009
Coursework: Quality Assurance & Regulatory Affairs in Pharmaceutical Industry -
University of Houston
Master's , Biology , 1985 — 1990
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State University of New York College at Oswego
Bachelor's , Zoology , 1978 — 1981
