Representing a pharmaceutical or medical device company to domestic and foreign regulatory agencies.
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Quality Control, Stability Coordinator, HPLC Lab Scientist, Quality Assurance, CAPA Coordinator, Investigator
EXECUTIVE SUMMARY
• Professional hydro geologist, highly experienced in development, management & protection of groundwater resources, watershed studies, surface/groundwater issues, landfill & contaminant sites characterization, land development and environmental impact studies.
• Highly experienced in project design & management, preparation of project proposals and technical reports, budgeting, liaison with clients and ...
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• Professional hydro geologist, highly experienced in development, management & protection of groundwater resources, land development and environmental impact studies expert., Highly experienced in project design & management expert, hydrogeological investigations, water well drilling, well designing / installation & developer, • Team player with strong interpersonal, communication, and time management skills.
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
Tags for this Online Resume:
Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs
Establish the strategic direction of a finance or audit function for a dynamic organization enhancing governance and operational performance.
Ideal Companies: Northwestern Memorial Hospital, Rush Medical Center
Tags for this Online Resume:
Audit, Evaluate, Compliance, Finance, Budget, Establish Policy, Establish Strategy, Manage, Direct, Supervise, MS Office, MS Excel Expert, HBOC, Meditech, Certified Internal Auditor, Save Millions of Dollars
Featured Profile
Where demonstrated strengths in the areas of accountability, problem solving techniques, and analytical skills that will contribute to Environmental regulatory agency compliance, through effective laboratory procedures and methodology working with R&D professionals insuring product quality and specifications assurance, that will lead to reduced overhead costs and increased profitability.
Water and wastewater professional with a class T-3 California water operator certification and more than three decades of experience within a public works organization with experience in all facets of the water and wastewater industry, including engineering, production, and distribution; public relations, including dealing with the news media and consumers in providing public education through presentations, and in maintain...
To obtain a senior position within an organization with opportunities to leverage my leadership and experience expertise as Chief Operating Officer/Chief Financial Officer/General Manager so to empower the organization to exceed its business goals.
I have extensive experience in the development of business initiatives and strategic planning, complemented by comprehensive financial responsibility and a proven track record ...
