Quality Manager with over 13 years of management and laboratory GxP experience in a pharmaceutical environment. Motivated, self-starter, highly organized, quick learner, dependable, strong team player with excellent communication skills.
Quality Management (QC, QA, QS)
Document Authoring and Management
Validation (Process, cleaning, test method, computer systems, spreadsheet)
Regulatory / Customer Audit Hosting
21CFR Parts 11, 58, 210, 211, 820, MHRA and HACCP compliance, 503B Compounding
Batch Record Review
OOS and Laboratory Investigation
Proficient in Microsoft Office
HPLC (Shimadzu, Agilent, PerkinElmer Series 200)
FTIR (Bruker Alpha, PerkinElmer Paragon 500)
Particle Size Analyzers (MicroTrac, Malvern, Air Jet Sieve, Ro-Tap)
Density determination (Auto-Tap)
Loss on drying (Denver IR-120, Denver IR-200)
UV/VIS Spectroscopy (PerkinElmer Lambda 10)
Gas Chromatography (GOW-MAC series 350)
QuVa Pharma – Bloomsbury, NJ
October 2018 – February 2019
Manager, Quality Systems - Laboratory
Responsible for ensuring that all laboratory investigations are conducted in compliance with internal procedures and FDA regulations.
Laboratory Investigations into OOS, atypical results, trends and deviations for both internal and contract laboratories performing analytical testing
Audits of laboratory systems to ensure compliance and data integrity
Implementation of CAPAs based on conclusions of investigations
Ensure housekeeping, instrument calibrations, preventative maintenance, training and GDP follow procedures and meet regulatory requirements.
Review and approval of IQ/OQ/PQ for laboratory equipment
Gap assessments and analysis of data to drive improvement
June 2018 – September2018
Manager, Manufacturing Quality Assurance/Sterility Assurance/ Lot Disposition
Responsible for all aspects of quality and sterility assurance in compounding, testing, packaging, labeling, batch release and shipping of sterile injectables.
Hired and managed a manufacturing QA team providing learning and development where appropriate
Make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
Review and approval of Deviations/Investigations, CAPAs, Change Controls and IQ/OQ/PQ
Process improvements to maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
Batch record review and disposition of bulk and finished compounded sterile products (CSPs)
Design and maintain the environmental / personnel monitoring and trending of related data
Periodic review of records to verify that quality standards for each drug product is met
Lonza Pharma & Biotech (formerly Capsugel and Powdersize) - Quakertown, PA
October 2005 – April 2018
October 2015 – April 2018
Responsible for all aspects of quality control and quality assurance for the particle size engineering of food, excipient, API and drug product intermediates.
Implemented Active Learner, TrackWise, Documentum, part 11 compliant software across all laboratory equipment, a Validation program for equipment and computer systems, a HACCP program, a risk management system and change control.
Authored/approved validation, quality and analytical documents.
Authored SOPs and forms for Quality and Production.
Managed QA and QC team, assign responsibilities, interview, hire and assist with training new employees.
Managed the QC laboratories.
Hosted Regulatory and Customer audits.
Set annual goals and continuous improvement initiatives.
Performed data integrity and part 11 compliance gap assessment.
Batch record review and batch release.
Interacted with the cross-functional teams.
Assistant Quality Manager
December 2011 – October 2015
Authored/approved laboratory investigations, deviations and OOS investigations.
Authored/approved SOPs, forms, validation protocols and reports.
Batch record review
Testing and sampling
Senior Quality Technician / Quality Technician
June 2008 - December 2011 / October 2005 – June 2008
Implemented EtQ Reliance Document Control (configuration, validation)
Tested samples: particle size (MicroTrac, Malvern, air jet sieve, Ro-Tap), density (Autotap), moisture analysis (loss on drying), identity (FTIR), residual (TOC, HPLC)
Sampled for microbiological testing: environmental monitoring, water, air, product contact and non-product contact surfaces.
Test method development and validation testing
Authored SOPs, forms, validation protocols and reports.
Batch record creation
Shipping and receiving
Giant Food Store - Allentown, PA
Assistant Bakery Manager / Bakery Associate / Pricing Coordinator
April 2002 - October 2005
Trained new employees, ordering, customer assistance, price changes, preparing and printing price change signs.
McDonald’s - Allentown, PA
August 1999 – March 2002
Trained new employees, maintained schedules, responsible for controlling inventory, customer assistance.
References available upon request