Experience

LAMPIRE Biological Laboratories, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director of Quality Assurance

  • Jul 2023 - Present

  Everett, PA

• QA Manager

  • Aug 2015 - Sep 2023

  Everett, PA



HarbisonWalker International

• Manager, QA Facility II

  • May 2016 - Aug 2016

  Sproul, PA



Adhesives Research, Inc.

• United States
• Chemical Manufacturing
• 100 - 200 Employee

• Quality Systems Engineer

  • Oct 2013 - Jul 2015

  Glen Rock, PA - Leader of project team meetings related to TrackWise workflow implementation and movement of paper-based systems to electronic workflows in the EQMS - Independently responsible for the configuration of workflows in the electronic TrackWise system - Author of validation protocols and reports for EQMS and other electronic systems - Solely Responsible for evaluation and approval of customer specifications and product-specifc agreements - Reduced customer specification… Show more - Leader of project team meetings related to TrackWise workflow implementation and movement of paper-based systems to electronic workflows in the EQMS - Independently responsible for the configuration of workflows in the electronic TrackWise system - Author of validation protocols and reports for EQMS and other electronic systems - Solely Responsible for evaluation and approval of customer specifications and product-specifc agreements - Reduced customer specification evaluation backlog while streamlining the evaluation and approval process - Acting as a daily quality consultant for operations and engineering regarding quality-related and system-related issues - Project leader in streamlining shelf life definitions over thousands of products - Initiation and execution of over 50 change controls

• Quality Assurance Specialist Group Leader

  • Aug 2009 - Oct 2013

  Glen Rock, PA Group Leader for the QA Product Release Group. - Reviewed and approved hundreds of manufacturing batch records. - Discussed issue resolution and assessed the need for nonconformance in conjunction with Operations - Created/approved roughly 200 product certifications per month - Released roughly 700 line order shipments per month - Streamlined product certification process to reduce time and resources involved in the process - Collaborated with customers… Show more Group Leader for the QA Product Release Group. - Reviewed and approved hundreds of manufacturing batch records. - Discussed issue resolution and assessed the need for nonconformance in conjunction with Operations - Created/approved roughly 200 product certifications per month - Released roughly 700 line order shipments per month - Streamlined product certification process to reduce time and resources involved in the process - Collaborated with customers on product certification requirements and customer specification/ control plan/ quality agreement details - Acted as a primary contact for Operations in regards to manufacturing compliance, documentation updates, non-conformance and change control needs. - Re-organized record retention process to increase efficiency - Supervised two full-time employees and one temp. employee over the term of the position - Responsible for performance evaluation for direct reports



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Stability Manager

  • Jun 2007 - Aug 2009

  Analytical Development, Stability group -- Manage the stability studies for various R&D viral and bacterial vaccine programs -- Manage the daily activities of five stability scientists -- Author/review/approve stability protocols and reports -- Implement stability study builds in LIMS system -- Perform statistical analysis on stability data for trending purposes -- Evaluate product expiration dating and extensions

• Research Scientist I & II

  • Jan 2004 - Jun 2007

  Analytical Development, Method Validation/Transfer group -- Responsible for authoring method validation and transfer protocols/reports associated with bacterial vaccine methods -- Responsible for the execution of validation and transfer protocols -- Managed transfer activities to various sites worldwide -- Served as SME on microbiological assays such as bioburden, sterility, endotoxin, etc... -- Approved routine testing data from contract test sites --… Show more Analytical Development, Method Validation/Transfer group -- Responsible for authoring method validation and transfer protocols/reports associated with bacterial vaccine methods -- Responsible for the execution of validation and transfer protocols -- Managed transfer activities to various sites worldwide -- Served as SME on microbiological assays such as bioburden, sterility, endotoxin, etc... -- Approved routine testing data from contract test sites -- Authored new standard test method procedures -- Performed assay qualifications and implemented new methods with assay robustness studies

• Glassware & Media Prep Supervisor

  • May 2002 - Dec 2003

  Process Development, Labware/Glassware & Media Prep Group -- Managed daily activities of up to ten technicians -- Reviewed sterilization and labware prep documentation -- Supervised media formulation and aseptic media filtration and fill operations -- Reviewed media preparation process batch records

• Scientist I & Associate Scientist

  • Feb 2001 - May 2002



Kelly

• United States
• Staffing and Recruiting
• 700 & Above Employee

• Technician

  • May 2000 - Feb 2001

  Temporary Position at Wyeth Research