W.Mark Smyth

W.Mark Smyth Email and Phone Number

W.Mark Smyth's Location
Greater Asheville, United States
W.Mark Smyth's Contact Details

W.Mark Smyth personal email

n/a
About W.Mark Smyth

W.Mark Smyth possesses expertise in medical devices, validation, chemistry, capa, quality control and 13 more skills.

W.Mark Smyth's Current Company Details

W.Mark Smyth Work Experience Details
  • Compli
    Senior Quality Specialist
    Compli Jul 2015 - May 2016
    South East
    Senior Quality Assurance SpecialistResponsible for the review of test method feasibility reports, method transfer protocols, and executed protocols. Review of compendia method verification protocols. Review of vendor equipment qualification protocols. Review of microbiologic data. Assist with Laboratory Investigations. Review of qualification/validation protocols associated with both production equipment and innovation development projects. Review of ongoing stability projects. Review of raw materials/components for release per site specifications. Some statistical analysis has been performed as requested. Currently a member of the site Quality Improvement Team that is chaired by the site QA manager.
  • Compli
    Consultant
    Compli Dec 2011 - Mar 2012
    Raleigh-Durham, North Carolina Area
    Consultant-laboratory remediation project in NC
  • Contract Position
    Quality Engineer
    Contract Position May 2011 - Nov 2011
    Usa
    Quality Engineer (May 2011– present, contract position) Investigate corrective and preventative action requests (CAPAs) and non-conformance reports (NCRs) to identify root causes. Develop and implement action plans to remediate these root causes. Ensures compliance with site and corporate quality standards. Work focused on activities in the synthesis lab.
  • Dietary Supplement Company
    Manager Quality Control
    Dietary Supplement Company Dec 2010 - Mar 2011
    Managed the QC operations at a site that manufactures dietary supplements.
  • Ucompli, Llc
    Senior Validation Consultant
    Ucompli, Llc Sep 2010 - Nov 2010
    Usa
    Performed method development & validation activities at a Medical Device company whose products include novel gas formulations, and gas delivery devices used in critical care hospital units.
  • Ctqpharma
    Principal
    Ctqpharma Dec 2008 - Sep 2010
    Greater Atlanta Area
    Consultant
  • Sss/Pfeiffer
    Analytical Services Manager
    Sss/Pfeiffer 2005 - 2007
    Responsible for managing the day to day Quality Control operations and compliance at a site that manufactures over the counter drug and cosmetic products.
  • Elan
    Manager Quality Control
    Elan 2001 - 2005
    Responsible for managing the day to day QC operations and compliance for a high sample throughput testing environment at a contract manufacturer of prescription drug products.
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  • Covance Laboratories
    Operations Manager: Chemistry Support And Formulations
    Covance Laboratories 1995 - 2000
    Responsible for managing the day to day lab operations and compliance of the Chemistry Support and Formulations departments at a Contract Research Organization.
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W.Mark Smyth Skills

Medical Devices Validation Chemistry Capa Quality Control Quality Auditing Gmp Software Documentation Six Sigma Quality Assurance Change Control Sop Fda Glp Manufacturing 21 Cfr Part 11 Pharmaceutics Pharmaceutical Industry

Frequently Asked Questions about W.Mark Smyth

What is W.Mark Smyth's email address?

W.Mark Smyth's email address is wm****@****uth.net

What skills is W.Mark Smyth known for?

W.Mark Smyth has skills like Medical Devices, Validation, Chemistry, Capa, Quality Control, Quality Auditing, Gmp, Software Documentation, Six Sigma, Quality Assurance, Change Control, Sop.

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