Experience

• 

  Dow chemical (kelly scientific)

  May 2001 - Mar 2005

  •Lead technologist responsible for testing an API, related raw materials and intermediates under cGMP practices•Aided project managers in the development of QC timelines for product launches •Operated HPLC, GC, FTIR, KF and titration equipment to test pharmaceutical raw materials and final products •Performed visual inspections of manufacturing equipment and assisted in the creation of cleanout procedures•Created SOPs and protocols and reports for the validation of analytical equipment•Provided new employee training Show less

  • Quality Control Analyst

    Jul 2002 - Mar 2005

  • Microbiology Technician

    May 2001 - Jul 2002
• 

  Avtech laboratories (now eurofins lancaster laboratories, inc.)

  Mar 2005 - Oct 2005

  Product testing analyst

  • Performed pharmaceutical product testing assays, USP dissolution tests and validation studies under cGMP regulations•Maintained, calibrated and troubleshot HPLC and GC equipment• Established and maintained data with the use of Excel, Word, Chemstation and Chemstore• Created and updated standard operating procedures• Facilitated OOS investigations

• 

  Corium international

  Oct 2005 - Dec 2008

  Quality assurance specialist ii

  • Served as quality/regulatory liaison for customers and internal operations for both new and existing medical devices and Rx pharmaceutical products.•Aided Project Managers in managing the quality unit activities (QA, QC and Document Control) to ensure all project documentation was completed and delivered to the appropriate customer before or on due-dates.• Worked with Operations, Engineers, R&D, and Quality to improve existing methods and processes.• Lead facilitator for CAPA, NCR, deviation, and customer complaint investigations.• Reviewed/interpreted SOPs, testing methods, and finished product/raw material specifications to ensure FDA, cGMP, ICH, and ISO compliance through appropriate change controls.• Created stability protocols and QA Agreements between Corium and Customers. • Aided in the design of raw material qualification, analytical method, and physical testing protocols and reports.• Conducted internal audits. • Provided company-wide training on quality procedures. Show less

• 

  Perrigo company plc

  Dec 2008 - now

  • Strategically evaluates and leads cross-functional teams to drive the Contract Sales continuous improvement project roadmap. This involves solving problems, enhancing processes, and increasing efficiencies across the business unit and with business partner COE teams, including Operations and Finance.• Develops best in class PMO capabilities and standards for which all contract project managers operate to support the business unit and our customers. This included creating a project management training program.• Responsible for overall pipeline management reporting for the business unit through use of Salesforce, Power BI reports, and Project Online providing status visibility to leadership. • Manage projects by collaborating with customer counterparts, account executives, and internal project teams to ensure on-time and on-budget project launches using the Stage Gate process.• Direct manager and mentor to senior project manager. Show less • Led multiple projects from initiation through launch with the use of the Stage Gate process. Types of projects include New Product Development, Product Evolution Management (life cycle/packaging changes) cost savings, tech transfers, and process improvement projects.• Managed and communicated change; resolving or escalating project issues using soft skills, and when needed, creating red flags and scope changes to overcome project obstacles.• Led and motivated both internal and external cross-functional teams (domestic and global); identifying resources needed, assigning individual responsibilities, and classifying critical path milestones.• Provided project status through presentations to top leadership, established Post Launch Reviews and Lessons Learned.• Responsible for effective execution, training, and ongoing improvement of the Stage Gate process.• SAP, SharePoint, Microsoft Outlook, Excel, OneNote and Microsoft Project software savvy.• Launched/completed over one hundred projects with a 95+ % on time success rate. Show less • Primary Quality Assurance reviewer and approver for Laboratory OOS/OOT investigations, quality events, and deviation investigations; ensuring that all information and documentation conforms to Perrigo policy, cGMP’s and all other applicable FDA guidance’s.• Provided quality oversight for other documents, including Calibration Non-Conformance Reports, residual solvent statements, Certificate of Conformances, stability project termination, and purchased material failures. • Through strong leadership and influential skills provided cGMP subject matter expert recommendations and risk assessment advice to a wide range of laboratory environments. • Supported both manufacturing and laboratory QAE duties for several months while the quality team encountered a staff shortage.• Led a Lean Sigma Green Belt project resulting in a 64.5% improvement in targeted measure. Show less • Reviewed and approved documents including Planned Deviations, Quality Incidents/Deviations, Annual Product Reviews and Calibration Non-conformances.• Ensured that all corrective and preventive actions created were consistent with the Company’s Standard Operating Procedures.• Worked with Operations, Engineering, Laboratory and Maintenance managers and staff to evaluate and develop action plans to ensure that the quality of the products and processes were consistent with current GMPs.• Placed suspect product on hold with use of SAP until investigations were properly conducted or authorization had been provided to ensure product was safe for consumer use.• Lead Quality representative for several Lean Sigma projects.• Completed Applied Statistics training through Perrigo - 2009.• Educated new employees on the roles of Quality Assurance Engineers, Continuous Improvement Engineers and the deviation process. Show less

  • Contract Sales Program Manager

    May 2022 - now

  • Senior Stage Gate Project Manager

    Dec 2011 - May 2022

  • Laboratory Quality Assurance Engineer II

    Oct 2010 - Dec 2011

  • Quality Assurance Engineer II

    Dec 2008 - Oct 2010