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Talented Validation and Quality Professional A highly skilled validation professional with over 15 years’ experience supporting the Bio-Pharmaceutical and Pharmaceutical industries and Possesses aptitude and appetite to quickly learn and apply evolving regulatory guidelines on emerging drugs. A graduate of Temple School of Pharmacy with an MS in Quality Assurance and Regulatory Affairs. Skills • Kaye Validator / RF Valprobe • SIMS, IRTD, and CTR-80 / CTR -25/140• Thermocouple Calibration• Facility Commissioning and Start-up• HVAC and Controlled Environments• Validation Risk Assessments• IOPQ protocols – author, review, execute, and summary reports• Spray Coverage Testing• Fermenters / Bioreactors• Process Vessels • Purification Skids• CIP systems• Purified Water Systems • WFI systems• Clean Steam Systems• Compressed Gases• Walk-in Cold Rooms & Temperature Chambers• Building Automation Systems • Cleaning Validation • Swab Sampling• Shipping Validation• Quality Systems• cGMP & FDA Compliance• SAP, CAMS,LIMS (administrator), Trackwise, E-doc, Livelink • Deviation investigations and CAPA• Safety Compliance
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Associate DirectorMerck Jan 2019 - PresentRahway, New Jersey, UsValidation Team Lead For Biologics and VaccinesValidation manager supporting CFR compliant equipment validation and life cycle oversite for COTS Analytical Equipment.
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Senior Validation Associate / Validation AssociateEndo / Auxilium Pharmaceuticals, Inc. Mar 2012 - PresentUsPerformed validation projects for a newly acquired sterile sustained release implant dosage form facility, including establishing environmental monitoring program, cleaning validation program, and in-process bioburden monitoringMaintain quarterly validation maintenance schedule to assure the validated state of all equipment is assessed on a routine basisIn support of the manufacture of a biologic bulk drug substance, prepare and review protocols, summary reports and SOPs relevant to validation and GXP operationsPerform temperature mapping and cleaning validation samplingParticipated on cross functional teams of inspection support staff and as a subject matter expert (SME) on validation for internal and external audits from regulatory agencies (FDA, EMA, Health Canada, and ANVISA (Brazil)) for pre-approval and routine inspectionsPrepared validation sections of CMC submissions, participated in audits from, FDA, EMA, Health Canada, and ANVISA (Brazil) regulatory agencies for pre-approval and routine inspections as inspection support staff and served as a subject matter expert (SME) on validation. -
Quality Assurance Specialist IiEndo / Auxilium Pharmaceuticals, Inc. Apr 2010 - Jun 2012UsQA Lead of analytical data review used for release, in-process, validation, stability and investigations.Prepared annual product review and documents for regulatory submissionsParticipated in internal and external audits as required Trended batch data in support of establishing key process indicators (KPI’s) and regulatory commitments Participated in final product release through batch record reviewReleased raw materials and consumables used in the manufacturing process
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Principal Validation SpecialistEndo Pharmaceuticals Oct 2017 - Jan 2019Malvern, Pa, UsValidation Specialist focused on Validation Maintenance, Data Integrity, Quality Risk Management, and Tech Services projects. -
Quality Assurance Associate I And IiBristol Myers Squibb ( Medarex) Nov 2005 - Mar 2010Lawrence Township, Nj, UsResolved batch record discrepancies using an inter-departmental approachIdentified non-conformances and deviationsTrained on all essential functions of LIMS administrator Approved Product Release and Stability Data in LIMS Compiled Release Documentation for clinical lots, reference standards, and stability Participated on the BLA/PAI preparation team Orchestrated review of product stability and evaluated results with cross-functional groups to ensure accurate stability reportsTrained employees on current procedures and GMP review of test methodsPerformed QA approval on raw materials and final container productsExecuted the review of manufacturing documents and QC test methods Launched initiative to archive non-pertinent clinical dataAuthored standard operating procedures and official documentation Managed inventory of retain and clinical supplies Performed vial and carton label review approval for clinical supplies -
Quality Control Officer/Laboratory TechnicianJet-Care International Aug 2004 - Nov 2005Reviewed, created and modified standard operating procedures and methodsEnsured instruments and methods were (ISO) compliantConducted numerous sample traces for internal and external auditsCalibrated and maintained laboratory equipmentResearched quality trends of laboratory equipment
Steven Woolery Skills
Steven Woolery Education Details
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Temple UniversityQuality Assurance And Regulatory Affairs -
Muhlenberg CollegeNatural Sciences
Frequently Asked Questions about Steven Woolery
What company does Steven Woolery work for?
Steven Woolery works for Merck
What is Steven Woolery's role at the current company?
Steven Woolery's current role is Associate Director at Merck Research Laboratories.
What is Steven Woolery's email address?
Steven Woolery's email address is sw****@****ail.com
What is Steven Woolery's direct phone number?
Steven Woolery's direct phone number is +178584*****
What schools did Steven Woolery attend?
Steven Woolery attended Temple University, Muhlenberg College.
What skills is Steven Woolery known for?
Steven Woolery has skills like Gmp, Lims, Quality Assurance, Sop, Validation, Fda, Pharmaceutical Industry, Biopharmaceuticals, Glp, Gxp, Biotechnology, 21 Cfr Part 11.
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