March 2026 to
Voyant Cosmetics, Ridgefield, NJ—Validation Consultant
| · Streamlining approach to Validating facility |
April 2025 to October 2025
CivicaRx, Petersburg, VA—Quality Engineer
| · Served as a Quality Engineering resource charged with review and approval of GMP/Quality Systems documents (protocols, reports, SOPs, Deviations). |
| · Provided expertise and directions to validation issues and activities conducted under GMP. |
| · Advised on document improvements to avoid issues during audits. |
| · Oversaw and approved commissioning documents, serving as gate-keeper for Commissioning to Qualification hand-off. |
June 2022 to January 31 2025
Resilience, Durham, NC—Technical Quality Resource
| · Served as a Quality Assurance Validation resource charged with review and approval of GMP/Quality Systems documents (protocols, reports, SOPs). |
| · Provided expertise on validation issues and activities conducted under GMP. |
February 2022 to May 2022
Thermo Fisher, Greenville, NC—Quality Assurance Deviation Investigator
| · Worked with newly formed team investigating and resolving deviations. |
| · Resigned from job as a result of family emergency. |
July 2021 to February 2022
Fresenius Kabi, Melrose Park, IL—(QD Design) Tech Transfer Consultant
| · Worked with Tech Transfer department in investigating and resolving deviations. Project initially identified as short-term project (less than 4 months) to assist in reducing manufacturing/process related deviations. However, duration currently exceeding 5 months. |
| · Deviations required use of Track Wise system, which served as a repository for deviations and on-going investigations. |
| · Extensive validation experience aided in zoning in on root-causes, leading to faster deviation resolutions. My presence has had a positive impact on reducing overall deviations. |
January 2021 to April 2021
ANTARES Pharmaceuticals, Minnetonka, MN—(Independent) Senior QA Consultant
| · Worked with Medical Device company on short term project (less than 4 months) to approve facility qualification documents |
| · Generated Quality System documents and served as Verifier/Approver for documents generated by others |
April 2018 to October 2020:
Xellia/Sagent Pharmaceuticals, Raleigh, NC—(Independent) Senior QA Consultant
| · Responsible for Quality Assurance Validation review for Qualification, Process Validation, and Tech Transfer activities |
| · Worked seamlessly with Tech Transfer and Validation groups, turning around critical documents received for approval within one day. |
| · Performed Vendor Management/Qualification |
| · Generation/Management of Supplier Quality Agreements (>100) for CMO |
| · Conducted batch record reviews |
| · Served as Compliance resource |
August 2016 to March 2018:
Xellia Pharmaceuticals, Cleveland, OH—Validation Reviewer/Technical Resource
| · Supported start-up of aseptic manufacturing process for site that was under Consent Decree. |
| · Performed Technical Reviews for aseptic equipment qualification and process validation effort. |
| · Provided leadership to Operations group on compliance, quality, technical and validation issues. |
| · Worked within focused system using Technical Writing skills to generate Operational SOPs for company recovering from Consent Decree. |
August 2016 to December 2016:
Xellia Pharmaceuticals, Raleigh, NC—Quality Assurance Compliance Specialist
| · Performed QA reviews for ongoing qualifications and process validations for sterile products. |
| · Responsible for initiating, presenting (to Change Control committee) and tracking Change Controls for new equipment and equipment changes in Trackwise. |
| · Responsible for reviewing site SOPs for accuracy and offering professional feedback. |
| · Responsible for Vendor Management/Qualification |
| · Responsible for leading formal Risk Assessments. |
March 2016 to June 2016:
Kremers Urban—Senior Validation Consultant
| · Responsible for overseeing and summarizing ongoing solid dosage process validations |
March 2014 to March 2016:
ProPharma Group, Overland Park, KS—SE Region Area Manager/Sr. Project Associate
| · As Regional Sales Manager, created strong client relationships and generated new business. |
| · Generated, approved and issued client service proposals. |
| · Performed EU Compliance audit. |
| · Managed regional budget. |
| · Performed Periodic Review and GAP Assessment for client Quality System. |
| · Generated Master Inventory Lists. |
| · Revised and generated client SOPs to assure audit readiness. |
| · Developed ‘Position Paper’ for packaging contractor for presentation to regulatory bodies. |
| · Executed Vendor IOQ for data loggers; mapped chambers using data loggers. |
January 2013 to December 2013:
Mallinckrodt/Covidien, Raleigh, NC—Independent Senior Consultant
| · Provided consultation to API manufacturer’s internal qualifications and process validations. |
| · Revised validation and re-validation SOPs. |
| · Revamped internal re-qualification program for equipment (inclusive of process equipment, instruments, and computer systems). |
| · Performed Validation Risk Assessments/audits and System Impact Assessments. |
July 2012 to December 2012:
Genzyme/Advent Engineering, Boston, MA—Consultant/CQV Lead
| · Lead/directed daily activities of CQV engineers on Consent Decree project. |
| · Managed team in a fast-paced, ASTM-E2500/Integrated C&Q environment. |
| · Authored and executed utility and equipment protocols and authored reports. |
| · Provided daily project status/updates to Senior Management. |
April 2012 to July 2012:
Genentech/Advent Engineering, Portland, OR—Senior Project Manager
| · Provided support to permanent Project Manager. |
| · Coordinated launch of high visibility, biotech derived oncology drug. |
| · Convened regular update meetings with core team members. |
July 2011 to April 2012:
Sanofi/Advent Engineering, Swiftwater, PA—COP Validation Lead
| · Led effort to develop and validate manual clean-out-of-place methods for vaccine product equipment. |
| · Managed day-to-day activities of and provided direction to 18 contractors. |
| · Generated and maintained resource schedules for cleaning operations. |
| · Approved development and validation documentation. |
| · Initiated deviations and worked with Quality, Technical Operations and Manufacturing to attain closure. |
June 2011:
Covidien/Jacobs Engineering, Raleigh, NC—Senior Validation Consultant
| · Wrote Validation Master Plan for plant revalidation. |
July 2010 to November 2010:
Hospira, Rocky Mount, NC—Senior Validation Consultant/Compliance Director
| · Performed Project Management for large Tech Transfer/validation projects (involved transfer and validation of equipment from continental US to Caribbean site). |
| · Managed inspection of vials and ampoules with automated vial inspection equipment. |
| (Note: attempted to launch personal product from November 2010 to June 2011) |
October 2009 to June 2010:
Sandoz, Wilson, NC—Senior Validation Consultant/Compliance Director
| · Performed Tech-Transfers, process optimizations, process and cleaning validation. |
| · Created/implemented GMP documents (batch records, tech transfer documentation, protocols, and reports). |
| · Assured that project documentation was compliant with internal procedures and regulations. |
| · Administered trainings on newly created Formulation Batch Records, SOPs, and Protocols. |
November 2008 to September 2009:
NNE Pharmaplan, Clayton, NC—Senior Consultant
| · Assisted with implementation of ASTM E2500 verification approach at client facility. |
| · Traveled to Asia to oversee and approve Quality Management System implementation/adherence. |
| · Upgraded and administered internal QMS and GMP trainings. |
| · Created accessible Global sales aide (for) Global corporate resources. |
December 2007 to November 2008:
NNE Pharmaplan, Clayton, NC—Regional Validation Manager
| · Provided management and leadership to team consisting of full-time and contract employees. |
| · Revised client-based documents to reflect new ICH Q9A, Draft Commissioning and Qualification Guide and ASTM E2500 guidelines. |
| · Generated, approved and issued client service proposals |
May 2007 to November 2007:
Pacific Bio-Development—Senior Validation Consultant
| · Provided QA review of processing/batch records and validation data. |
May 2005 to April 2007:
Diosynth-RTP (Fuji Film)—Sales Development Manager
| · Provided sales support for Sales & Marketing Department. |
| · Authored proposals with an average annual value over $100 million. |
| · Identified and implemented measures to increase departmental efficiency and productivity. |
May 2003 to May 2005:
Diosynth-RTP (Fuji Film)—Manager, QA Validation
| · Provided QA and Compliance oversight to and direction for qualifications and process validations for Bio-tech CMO. |
| · Implemented validation guidelines, policies, procedures and master plans. |
| · Responsible for plant wide QA compliance. |
April 2001 to May 2003:
Diosynth-RTP—Manager, Capital Projects Equipment Qualification
| · Managed team consisting of permanent and contract resources for Bio-tech CMO. |
| · Collaborated with Quality to define/establish strategy for qualifying Bio-tech equipment. |
| · Collaborated with key departments to implement new validation tools and standards. |
| · Instituted communications forum for operations management. |
| · Prepared subordinates for periodic Bio-tech regulatory audits. |
| · Represented Equipment Qualification in regulatory and client inspections/audits. |
June 1999 to April 2001:
BE&K Engineering, RTP, NC—Validation Lead
| · Provided quality and validation consulting. |
| · Wrote Validation Master Plans for multi-million dollar projects. |
| · Designed, qualified and implemented innovative QC tool for routine sampling. |
August 1993 to May 1999:
TheraTech, Inc., Salt Lake City, UT— Senior Validation Engineer/Associate Director, Transdermal Development; Department Head, Validation and Production
| · Responsible for manufacturing processes functioning properly and delivering quality product. |
| · Collaborated with Quality to enforce Corporate Qualification and Process Validation Policy and Corporate Validation Change Control Policy, which were authored by me. |
| · Facilitated internal development-to-manufacturing technology transfers. |
| · Prepped Validation Department for Pre-Approval Inspections (PAI). |
| · Represented Transdermal Validation in PAIs. |
| · Developed/implemented strategy for equipment qualification and process and cleaning validations for start-up company. |
| · Created and implemented validation program which included a documentation system complete with corporate level, transdermal-specific process validation procedures. |
September 1989 to August 1993:
Marion Merrell Dow, Kansas City, MO—Senior Process Engineer/Project Manager
| · Coordinated tech-transfers of processes from Development to Manufacturing and from US to Europe. |
| · Authored validation protocols, summaries and manufacturing records for sterile drugs, devices, solid dosages and liquids. |
| · Implemented process for new, sterile injectable product at international site. |
| · Managed successful market launch of high-volume heart drug. |
| · Managed execution of equipment qualifications and process validations. |
June 1980 to September 1989:
Bristol Myers, Evansville, IN—Senior Process Engineer
| · Supported sterile drugs, solid doses, and liquids. |
| · Collaborated with Quality to define/establish strategy for equipment qualification and process validation. |
| · Authored qualification and process validation protocols/summaries and manufacturing records for sterile drugs, solid dosages and liquids. |
| · Executed equipment qualifications and process validations. |
| · Led Tech Transfer for sterile oncology product from IN to Caribbean site, developed and implemented novel lyophilization process. |
November 1978 to June 1980:
3M, St. Paul, MN—Process Development Engineer
| · Researched, developed and optimized synthesis routes for photographic film dyes in laboratory environment. |
| · Scaled-up processes and coordinated transfers to Pilot Plant. |
