Gordon E. Email & Phone Number

Work program managementCommittee management and general supportManagement of meetingsProject management

Toledo, Ohio Area

Leading efforts in design and validation of cleanroom and other controlled environments for the medical device, pharmaceutical, biologics and compounding pharmacy industries as well as the development of environmental monitoring program master plans and risk assessments.Work on sterility assurance projectsManage projects such as container closer integrity (CCI) testing and sterilization studies. Technical reviewer for AET, BI incubation reduction studies and others as assigned

Greater Atlanta Area

Providing consulting services in the areas of sterility assurance, contamination control, cleanrooms, microbiology, packaging, validations and other quality aspects for the medical device, pharmaceutical, biologics and other related industries.I don't take on work currently but am willing to answer questions.

Marietta, Ga

Lead team of quality engineers in main facility and work with leads at other company facilitiesPerform supplier quality auditsPerform internal process and facility inspectionsReview and approve quality documentsWork with other quality teams and operations within companyApprove preventive and reactive maintenance records Validate or qualify processes and equipmentProvide expertise on cleanroom operations and sterilization processesParticipate with standards and regulatory writing organizations

Marietta, Ga

Communicate regulatory information to the company and ensure that information is interpreted correctly.Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.Maintain current knowledge of relevant regulations, including proposed and final rules.Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.Provide responses to regulatory agencies regarding product information or issues.Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Develop regulatory strategies and implementation plans for the preparation and submission of new products.Direct the preparation and submission of regulatory agency applications, reports, or correspondence.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.Train staff in regulatory policies or procedures.Participate as active working group member within ISO, AAMI and IEST and be involved in other standards organizations related to the medical device/pharmaceutical/biologics industries.

Greater Atlanta Area

Provide site expertise on regulations and standards related to the medical device, pharmaceutical, biologics and similar industries.Member of Regulatory Affairs Council for WuXi's U.S. operations.Participate as active working group member within ISO, AAMI and IEST and be involved in other standards organizations related to the medical device/pharmaceutical/biologics industries.Oversee program development and implement new technologies such as rapid microbiology methods.Assist clients with technical and regulatory issues.Work with clients to develop custom studies.Offer technical support for all microbiological issues within the laboratory.Write price quotes and protocols.Provide consulting services to clients on cleanrooms, environmental monitoring and sterilization validations.

Greater Atlanta Area

Oversee Microbial Assays and Specialized Studies departments.Provide technical support for all microbiological issues.Work with the Senior Director of Operations to improve the overall quality of the departments.Work with the Senior Director of Operations on new projects and endeavors.Mentor the growth and career development of direct reports.Work with clients to develop custom studies.

Greater Atlanta Area

Oversee all microbiology departments.Provide technical support for all microbiological issues.Work with the Senior Director of Operations to improve the overall quality of the microbiology departments.Work with the Senior Director of Operations on new projects and endeavors.Mentor the growth and career development of direct reports.

Greater Salt Lake City Area

Day-to-day leadership of the validation efforts and processes of the laboratory.Deliver validation services, functioning as the technical process validation expert; ensuring laboratory processes are validated in accordance with established regulations and approved quality standards and procedures; including development of validation master plan, document generation and protocol execution.Provide training accordingly for implementation of validated procedures. Coordinate and/or conduct training in validation procedures.Implement industry standards, determine acceptance criteria and approve validation protocols for the validation of facilities, utilities, computers, cleaning, equipment and change control administration.Generate validation summaries and defend validation executions and conclusions to regulatory authorities and external auditors during inspections.Provide master planning and administration of Validation Plans and Validation Master Protocols which outline the scope and approach of the validation effort for major projects.Develop and maintain databases to track the status of validation activities. Issue reports.Interface with Corporate, Laboratory, QC and QAU to assure completion of validations.Evaluate the impact of changes on validated systems and approve or recommend acceptance criteria to proposed changes. Propose solutions to investigational problems based on the data.Oversee acceptance of critical supplies, controls, and reference materials.

Greater Salt Lake City Area

Supervise section personnel (specifically study directors in the Microbial IDs and Packaging departments) Conduct section meetings.Conduct marketing/customer service sponsor visits.Assist with development and promotion of design review consulting.Attend meetings to keep current with new technical information.Teach technical training sessions as assigned by the training department.Ensure that personnel have proper documentation for applicable studies.Review scientific literature.Receive and conduct tests on samples.Generate standard operating procedures.Write final reports and protocols.Interface with sponsors.Review and recommend laboratory price changes.Generate control samples and data for tests of responsibility.Maintain quality control charts for control samples.Perform validations for personnel and tests of responsibility.Know and follow GLP and GMP regulations, ISO 17025 and ISO 9001 guidelines.

Greater Salt Lake City Area

Package testing (Accelerated Aging, Burst, Creep, Bubble Emission, Dye Migration, Seal Peel, Microbial Aerosol Challenge)Growth Promotions-Sterility MediaBacteriostasis/FungistasisProduct SterilityBiological Indicator (BI) sterilityBioburdenMicrobial identificationsReview scientific literature.Receive and conduct tests on samples.Generate standard operating procedures.Write final reports and protocols.Interface with sponsors.Know and follow GLP and GMP regulations, ISO 17025 and ISO 9001 guidelines.

Greater Salt Lake City Area

Supervise section personnel (specifically study directors in the Bioburden, Radiation, Sterility, and Microbial IDs departments) Conduct section meetings.Conduct marketing/customer service sponsor visits.Assist with development and promotion of design review consulting.Attend meetings to keep current with new technical information.Teach technical training sessions as assigned by the training department.Ensure that personnel have proper documentation for applicable studies.Review scientific literature.Receive and conduct tests on samples.Generate standard operating procedures.Write final reports and protocols.Interface with sponsors.Review and recommend laboratory price changes.Generate control samples and data for tests of responsibility.Maintain quality control charts for control samples.Perform validations for personnel and tests of responsibility.Know and follow GLP and GMP regulations, ISO 17025 and ISO 9001 guidelines.

Greater Salt Lake City Area

Greater Salt Lake City Area

Bs, Microbiology, General

Education record