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Work Background
Polysciences, Inc.Quality Assurance Specialist
Oct. 2023 - Feb. 2025Warrington, Pennsylvania, United States
BioAnalysis, LLCDirector Of Quality
Jan. 2021 - Jun. 2023Philadelphia, Pennsylvania, United States
AbzenaQuality Assurance Supervisor
Sep. 2019 - Jan. 2021Bristol, Pennsylvania
AbzenaQA Associate
Nov. 2018 - Sep. 2019Bristol, Pennsylvania- Review batch records to ensure compliance with SOPs and CGMPs.
- Review and approve materials for use in GMP Manufacturing. - Maintain the document management system and document master files.
- Assist Quality Management in continuous evaluation and improvement of Quality Systems and procedures while independently identifying areas for improvement.
- Oversee and maintain all operations associated with the QMS.
- Manage the training program for site employees and contractors.
- Assist in internal audits and serve as a subject matter expert.
GlaxoSmithKline Manufacturing Supervisor
May. 2017 - Oct. 2018Rockville, Maryland
VALSPECTechnical Team Lead/Documentation Specialist
Sep. 2014 - Apr. 2017On assignment at GlaxoSmithKline in King of Prussia, PA
- Use the Controlled Document Management System
- Complete the Document Compliance Editing Check on Controlled Documents (SOPs, Instructions, Material Specifications, Analytical Methods, Validation Protocols, etc) prior to sending for review and approval
o Ensuring the documents comply with Biopharm Document Editing conventions and Biopharm SOPs, GSK SOPs and Global Quality Policies for controlled documents
- Assist Authors in creating documents and workflows in CDMS
- Assist Authors with the use of Microsoft Word advanced functionality (styles, cross-references, tables, pictures, embedded objects, etc.)
- Ensure that documents rendered properly in CDMS and troubleshoot any rendering issues
- Ensure the appropriate reviewers and approvers are assigned to documents
Lyophilization Technology, Inc.Document Control Specialist
Jun. 2008 - Sep. 2014As part of the Quality Assurance group, I reported directly to the Vice President, Scientific Affairs. I was responsible for the training program, maintaining documents and archival needs for our company. I developed a new logbook system, implemented across the organization.
Lyophilization Technology, Inc.Clerical Assistant
Mar. 2007 - May. 2008Reported directly to the Business Operations Manager.
Office TeamAdministrative Assistant
Sep. 2006 - Feb. 2007Ivyland, PAOn assignment at Lyophilization Technology, Inc.
Starbucks Coffee CompanyShift Supervisor
Jul. 2005 - Jan. 2007As a shift supervisor, I trained new employees, secured company assets and offered seminars to customers as a Coffee Master.
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