Shawntel Christian
Miami,Fl
Summary
Detail-oriented Quality Professional with 15+ years of experience in pharmaceutical and biologics manufacturing, supporting batch record review, regulatory documentation, and GMP compliance in startup and high-growth environments. Proven ability to review high-volume batch records with >99.5% accuracy, verify critical documentation entries, and resolve discrepancies to support right-first-time batch release. Experienced in SOP and batch record revisions, cross-functional collaboration, and maintaining audit-ready documentation while meeting FDA, cGMP, and AATB requirements. Recognized for strengthening documentation accuracy, supporting efficient scale-up, and contributing to compliant, on-time production.
Overview
15
15
years of professional experience
Work History
QA Batch Record Reviewer I
Vivex Biologics
01.2025 - Current
- Perform technical review and final disposition of 70+ batch records per week, ensuring compliance with FDA, cGMP, SOPs, and accreditation standards prior to release.
- Verify hundreds of required batch record entries per batch (processing data, QC results, sterilization/irradiation records, labeling accuracy, and packaging integrity), maintaining >99.5% documentation accuracy and supporting right-first-time batch release.
- Identify, document, and resolve documentation discrepancies per week, collaborating with Manufacturing, Operations, and Quality to obtain corrections without delaying release timelines.
- Track work-in-progress (WIP) through completion and update inventory and disposition status in BTM, ensuring accurate traceability, inspection readiness, and on-time fulfillment of customer orders and backorders.
- Support SOP and batch record revisions, deviation reporting, and nonconformance documentation, contributing to audit-ready records and successful regulatory inspections.
Fill Finish Tech II
ADMA Biologics
01.2020 - 01.2022
- Executed and documented GMP sterile fill-finish operations for 1,000+ units per shift, ensuring compliance with aseptic processing and regulatory requirements.
- Reviewed and completed real-time batch record documentation, supporting right-first-time documentation and timely QA batch release.
- Assisted in revising SOPs and batch records during startup and scale-up activities, improving documentation clarity and reducing repeat documentation errors.
- Identified documentation discrepancies and supported deviation investigations and corrective actions, contributing to reduced rework and improved release timelines.
- Collaborated with Quality and Manufacturing teams to maintain inspection-ready documentation during internal and regulatory audits.
Manufacturing Tech II
Teva Pharmaceuticals
01.2011 - 01.2020
- Supported high-volume GMP manufacturing operations, completing and reviewing complex batch records with >99% documentation accuracy.
- Participated in process startup and restart activities, including the laser drill process overhaul, contributing to improved documentation accuracy and production efficiency.
- Assisted in revising SOPs and batch records, ensuring alignment with regulatory expectations and manufacturing usability.
- Verified material traceability, process parameters, and equipment documentation, ensuring compliance with FDA and cGMP requirements.
- Partnered with Engineering and Quality to identify documentation gaps, reduce rework, and support audit-ready manufacturing operations.
Education
Associates Degree - undefined
Miami Dade College
01.2016
Skills
Problem Solving & Error Resolution
Timeline
QA Batch Record Reviewer I
Vivex Biologics
01.2025 - Current
Fill Finish Tech II
ADMA Biologics
01.2020 - 01.2022
Manufacturing Tech II
Teva Pharmaceuticals
01.2011 - 01.2020
Associates Degree - undefined
Miami Dade College