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.

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.

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.

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.

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.

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.

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.

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.

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.

Greater Salt Lake City Area

Greater Salt Lake City Area

Bs, Microbiology, General

Education record