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Q&A With Sheniequa Glover

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Sheniequa Glover
Clinical Project Lead Specialist, Resilience, Inc.

Location: Lansdale, PA United States
Birthday: Jul 16th
Joined: Sep 7th, 2023
About   (request update)
Greetings!

I am a Quality Professional with over 20 years experience in the pharmaceutical industry (Manufacturing and Biotech). I possess experience in contract manufacturing, vaccines and biologics, clinical supplies and packaging, and External Manufacturing.
Education   (request update)
Lincoln University -Pennsylvania class of 1998
Undergrad Major: Biology
Campus Organization:
Zeta Phi Beta
Most Memorable Moment:
Chicken Night (long lines and tupperware) Parties at the Sub phones in the dorm hallways Homecoming the Quad Chemistry Lab Making lasting friendships
Experience
I currently work with Resilience, Inc. as Clinical Project Lead Specialist
I have 18 years of experience working in the Biotechnology and Pharmaceutical industry.
Clinical Project Lead Specialist | Resilience, Inc.
From January 2023 to Current • 1 year(s)
Clinical Project Lead Specialist • Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program. • Build strong relationships and collaborate closely with Clients as well as internally with the CMC/Operations/Development teams. • Participate in all Client meetings and provide updates to Quality management. • Be the lead for Quality on Client activities and communications. • Organize and manage scheduling Client visits and audits, as needed. • Provide oversight over all Client change requests and providing all client notifications for quality records. • Review and approve deviations, change controls and/or CAPAs, as needed. • Negotiate Quality Agreements with new Clients. • Participate in Client audits.
Quality Analyst | Johnson & Johnson, Inc.
From November 2021 to January 2023 • 2 year(s)
• Supports EMQA Quality Leads and Quality Account Managers through various projects and quality/compliance improvement activities in EMQA • Represents EMQA on projects and improvement teams to guide quality/compliance requirements • Supports batch record review and batch disposition of US Self Care drug products from external manufacturing and packaging sites • Supports the processing of retain samples from external packaging sites • Supports the distribution and tracking of implementation of analytical methods and specifications at EM sites • Supports the tracking of microbiological samples and results from external contract laboratories
Senior Quality Specialist, CMO Quality Management | Sanofi, Inc.
From October 2014 to November 2021 • 7 year(s)
• Responsible for direct to patient activities for Gene and Cell Therapy projects • Coordinate review and approval of Master and Executed Batch Records • Collaborate with Packaging group to identify and investigate Deviations and customer complaints; helps drive Corrective and Preventative Actions (CAPAs) as appropriate • Provide Quality insight during Project Management meetings • Present data during Site Quality Council meetings • Responsible for performance of Quality Risk/Impact assessments of vendors and suppliers • Performs external audits of potential and existing Suppliers • Provides oversight of Vendor Audit Program • Manages Supplier Management System for the site • Performs release of Investigational Medicinal Products and components • Manage the Quality Technical Agreements to ensure new agreements are written and approved before new critical vendors or contractors are utilized
Quality Specialist | Merck & Co., Inc.
From August 2010 to October 2014 • 4 year(s)
• Provide support directly to the production floor via batch record and logbook audits, provides coaching and mentoring of manufacturing supervisors and operators completing documentation • Coordinate with production to discuss, resolve, and eliminate documentation observations • Ensure compliance with internal, FDA, and other regulatory agency requirements • Actively participate in the Tier process and uses this forum to escalate concerns and best practices • Perform Quality review of new and updated Site Master Formulas • Update and review Standard Operating Procedures (SOPs) • Participate in aseptic process simulations for Rotateqฎ • Work with Deviation Management Team to implement corrective and preventive actions (CAPAs)
Quality Assurance Associate II | Eisai Inc.
From September 2008 to August 2010 • 2 year(s)
• Initiate complaint investigations and communicate directly with doctors and staff regarding adverse events • Successfully completed Annual Product Review of medical device for review and approval • Initiate investigations, perform root cause analysis, and determine corrective/preventive actions (CAPAs) • Review completed Investigations and Deviations for potential impact on batch record documents • Audit manufacturing records and related documents for completeness and accuracy • Initiate actions as required to correct/complete batch records and/or related documents, dispositions all batch records
Quality Assurance Associate (Contractor, Aerotek Scientific) | Lonza, Inc.
From April 2008 to September 2008 • 0 year(s)
• Review batch records for adherence to company policies and GMPs • Organize files and filing systems, Maintain GMP training systems • Verify/review accuracy of databases, logbooks, and spreadsheets • Notify supervisors of any variants to review of batch record, issuance, or non-conforming incidents
Quality Assurance Associate II | AppTec, Inc.
From October 2005 to April 2008 • 3 year(s)
• Review/approve Testing, Manufacturing and Product Development batch records • Review and approve deviations, investigations, and Out of Spec occurrences • Review Validation and In-process reports • Inspect steps in cell banking, virology, and analytical chemistry lab studies
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Guestbook Comments
It's my pleasure to have you join, us as a new or seasoned member. May you have an amazing, blessed and marvelous day
Tagged by Ralph White on 09/07/2023  
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