Experience

Triclinic Labs, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Quality Assurance Specialist

  • Apr 2022 - Present

• Quality Assurance Specialist

  • Jul 2020 - Apr 2022



Self-Employed

• Independent Quality and Compliance Consultant

  • Jul 2016 - Apr 2019

  • Maintained a robust Quality Management System, including procedures, training, change control and risk management.• Knowledgeable of ISO standards (ISO 13485, ISO 9001 and ISO 22442-2), 21 CFR 820 and other relevant FDA requirements as applied to medical device manufacturing and quality.• Point of contact and participated in external audits and inspections conducted by customers and/or ISO certification body.• Performed, documented, reviewed and closed internal and supplier audits.• Facilitated the review and resolution of deviations, non-conformances and proposed Corrective and Preventive Actions (CAPAs).• Ensured the document management system, including writing, revising and maintaining procedures, procedure tracking and procedure training was kept up to date.• Maintained and updated the quality manual and guidelines.• Prepared management reviews and conducted reporting meetings.• Performed quality review of training records to ensure compliance with procedures and regulations.• Facilitated the change control process through working with change owners and customers as required.• Completed batch record reviews and release of product to customers.• Facilitated the investigation and follow-up of product quality complaints.• Reviewed equipment calibrations, validations and maintenance records to ensure compliance.• Evaluated compliance risks and assisted in developing risk mitigation strategies.



Evonik

• Germany
• Chemical Manufacturing
• 700 & Above Employee

• Senior Quality Assurance Representative

  • Jan 2010 - Jan 2013

  • Inspected and reviewed incoming raw materials shipments for manufacturing and export of manufactured products prior to customer shipments.• As site contact for procedures, assisted in the reduction of the number of procedures for the site by 75% resulting in a savings of $90,000.• Prioritized the sampling and analysis of raw materials for processing to ensure timelines for projects were met.• Approved raw materials and packaging materials which included the review of analytical data and certificates of analysis, conformance and/or testing from the supplier.• Consulted and collaborated on materials issues with support personnel from manufacturing, warehousing, analytical laboratories, engineering, planning and purchasing.• Provided project management interaction with internal customers.• Interacted with suppliers of raw materials for the entire site.• Created, reviewed and approved procedures and specifications for both raw and manufactured materials.• Assisted with deviations related to both raw and manufactured materials.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Quality Assurance Representative

  • Jan 2000 - Jan 2010

  • Provided quality support for incoming raw materials, purchased materials and site manufactured materials which included bulk pharmaceuticals, animal health products and development processes.• Participated in various inspections including site-self inspections, FDA audits and mock pre-approval inspections.• Assisted with the implementation of Regulus (a computer-based document warehouse) as part of a Six Sigma team which reduced the time for revision, review and approval of procedures from over 9 months to 3 months.• Knowledgeable of good manufacturing practices (GMPs) including applicable procedures, specifications, regulations and standards.• Created and delivered training including several courses related to conduct of GMP in manufacturing and proper documentation on GMP related documents for employees and contractors.• Reviewed, wrote and implemented process change controls.• Released 45 batches of animal health product within a 4-month timeframe in order to meet customer commitment dates.• Initiated and implemented stability protocols for manufactured materials.• Reviewed and monitored data for batch production and release.• Assisted in the reduction of the backlog of out-of-date compliance procedures from over 100 at the start of the year to less than 20 by the end of the year.• Addressed and assisted in resolving customer complaints for manufactured materials.• Reviewed and approved master processing tickets for production.• As the United Way site representative in 2005, led the site in raising over $500,000 for the annual community campaign (goal was $470,000).



Bioanalytical Systems, Inc.

• Biotechnology Research
• 100 - 200 Employee

• Analytical Chemist

  • Aug 1997 - Jan 2000

  • Performed contract laboratory analysis of stability samples utilizing good laboratory practices (GLPs).• Advised with external customers on the resolution of issues and concerns which often included travel to the customer’s locations. • Performed contract laboratory analysis of stability samples utilizing good laboratory practices (GLPs).• Advised with external customers on the resolution of issues and concerns which often included travel to the customer’s locations.



Purdue University

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Research

  • Jan 1996 - May 1996