TAWANA JONES
West New York,NJ
Summary
Detail-oriented Compliance Specialist with over 10 years of experience in quality assurance, regulatory compliance, and non-conformance management within the pharmaceutical industry. Proven expertise in investigating, authoring, and managing Non-Conformance Reports (NCRs), assigning and tracking Corrective and Preventative Actions (CAPAs), and conducting Effectiveness Checks (ECs). Skilled in root cause analysis, data analysis, and collaborating with cross-functional teams (production, quality control, quality assurance, facilities) to streamline processes and resolve non-conformance issues efficiently. Committed to maintaining strict compliance with cGMP, ISO 9000, and FDA regulations, consistently contributing to timely and compliant operations.
Overview
18
18
years of professional experience
Work History
Regulatory Site Officer
Sanofi
07.2023 - Current
- Investigated and approved deviations (NCRs) to ensure compliance with regulatory requirements.
- Completed US annual submissions for multiple products, including Mozobil, Lovenox, and Hectorol, on time.
- Performed regulatory reviews, assessments, and developed regulatory strategies for Change Control Requests (CCR) and Supplier Change Notifications (SCN) within Phenix and QualiPSO.
- Led Lovenox regulatory activities, assessing the regulatory impact of changes and participating in regulatory change control (CCP) meetings.
- Collaborated with cross-functional teams to expedite regulatory assessments and meet business needs, including managing multiple priorities and urgent changes.
- Created a spreadsheet to identify current Common Technical Document (CTD) sections for different dossier sections across US, EU, Canada, Australia, and New Zealand markets.
- Authored and submitted US Annual Reports for Lovenox, Mozobil, and Hectorol as per reporting schedule.
- Trained new Regulatory Site Officers on regulatory submission writing and annual report preparation.
Compliance Specialist Lead
Sanofi
05.2022 - 07.2023
- Led complaint investigations, ensuring completion within the 35-day target timeframe, and eliminated a backlog by completing site investigations within targeted days.
- Assisted the batch release team in reducing a 100+ batch record backlog to less than the target of 27, meeting departmental KPIs and ensuring timely release of investigational and commercial drug products.
- Authored a major RQN (Regulatory Quality Notification) for Lovenox, presented to global quality, demonstrating strong written communication skills.
- Streamlined the complaints department by querying weekly reports to ensure timely complaint closure, improving overall cycle time.
- Supported the release team during the Fluzone campaign, ensuring lots were released within target timeframes.
- Participated in weekly Right First Time meetings with manufacturing and conducted one-on-one discussions to assure good documentation practices and GMPs were followed.
Compliance Specialist Senior
Sanofi
09.2019 - 05.2022
- Ensured batch records were released in a timely manner to prevent inventory market stock-outs, consistently meeting the KPI of less than 27 BPR backlog metrics weekly.
- Investigated root causes of customer complaints, collaborating with cross-functional teams (Engineering and Packaging).
- Implemented an in-process control in the Batch Production Record (BPR) with the Packaging department, resulting in a 98% decrease in perforation customer complaints.
- Qualified as a Visual Inspector for AQL Inspection to support manufacturing operations.
- Assisted in process improvement initiatives to ensure preventative and corrective actions for customer complaints were addressed.
- Prepared Periodic Product Review (PPR) reports for Lovenox.
- Updated and revised SOPs.
Compliance Specialist / Manufacturing Coordinator
Teva Pharmaceuticals
03.2014 - 10.2017
- Reviewed real-time and final Manufacturing batch production records in compliance with cGDPs, cGMPs, internal and regulatory specifications/regulations to ensure timely release.
- Initiated, executed, and closed batch-related deviations, change controls, and CAPAs in quality and other compliance databases (SAP, QUMAS, Trackwise).
- Identified, documented, and notified area supervision of personnel documentation error trends during product batch review.
- Collaborated with Manufacturing and QA to streamline Right First Time (RFT) incentive, coordinating monthly meetings to identify and correct error trends.
QC Incoming & Receiving Inspector / QC Inspector
Compass Pharma Services
12.2007 - 06.2011
- Performed AQL sampling, including normal, reduced, and tightened inspections, following ISO 9000 guidelines.
- Sampled and inspected raw materials and components as established by specifications and customer requirements.
- Monitored production processes at pre-determined intervals for physical defects, weight controls, and correct physical measurements.
- Ensured documentation and verifications (calibration, laboratory testing, bulk, and components) were complete prior to production.
Education
Bachelor of Arts - Operations Management & Analysis
Ashford University
San Diego, CA06-2012
Skills
- Compliance & Quality: Non-Conformance Report (NCR) Management, Corrective and Preventative Action (CAPA) Implementation, Effectiveness Checks (EC) Execution, Root Cause Analysis, GMP and FDA Regulatory Compliance, Quality Assurance, Batch Record Review & Release, Deviations, Complaints Management, Process Improvement, SOP Development & Revision, AQL Inspection
- Technical & Systems: Microsoft Office Suite (Excel, Word), Quality Management Systems (SAP, QUMAS, Trackwise, COMET), Phenix, QualiPSO, Documentation Management & Review, Data Analysis
- Professional & Interpersonal: Cross-functional Team Collaboration, Strong Written & Verbal Communication, Problem-Solving, Investigative Skills, Attention to Detail, Time Management, Organizational Skills, Adaptability, Independent Work
- Report preparation
- Investigation leadership
- Reporting and documentation
- Teamwork and collaboration
- Organizational skills
- Problem-solving
- Attention to detail
- Decision-making
- Time management
- Written communication
- Quality assurance
- Self motivation
Timeline
Regulatory Site Officer
Sanofi
07.2023 - Current
Compliance Specialist Lead
Sanofi
05.2022 - 07.2023
Compliance Specialist Senior
Sanofi
09.2019 - 05.2022
Compliance Specialist / Manufacturing Coordinator
Teva Pharmaceuticals
03.2014 - 10.2017
QC Incoming & Receiving Inspector / QC Inspector
Compass Pharma Services
12.2007 - 06.2011
Bachelor of Arts - Operations Management & Analysis
Ashford University
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