Shalom Chausarira
Cary,NC
Summary
Quality control professional with track record of ensuring product integrity and compliance . Known for attention to detail and collaborative approach to improving processes. Reliable and adaptable, bringing strong analytical and problem-solving skills to every project.
Overview
7
7
years of professional experience
Work History
Quality Control Associate III
Biogen
Morrisville, NC
08.2023 - Current
- Biologics / GMP Manufacturing Environment
- Own authorship, investigation, and closure of OOS, atypical results and laboratory deviations in TrackWise.
- Perform comprehensive root cause analysis using audit trails (Empower, LIMS), batch records, logbooks, calibration records, and trend data.
- Lead CAPA development, implementation, and effectiveness verification to prevent recurrence.
- Conduct raw material testing including compendial and non-compendial methods, maintaining 100% on-time metric record.
- Perform TOC and Conductivity testing for Manufacturing and Environmental Monitoring, 40-60 samples on average.
- Perform audit trail review for chromatography systems and QC instruments to ensure compliance with ALCOA+ principles.
- Investigate analyst, reagent, instrument, and method-related failures.
- Author and edit GMP documents in Veeva Vault; create and route workflows for SOP revisions, change controls, and investigation approvals.
- Support inspection readiness and respond to internal audit inquiries related to investigations and CAPAs.
- Key Systems: TrackWise, Veeva Vault, Empower, LIMS
Quality Control Associate II
Biogen
Morrisville, NC
03.2022 - 07.2023
- Performed raw material and release testing for raw materials and drug products, consistently met metrics.
- Initiated and supported OOS and deviation investigations in TrackWise, 3-5 investigations monthly.
- Conducted data review for GMP compliance and audit trail verification, releasing 5-10 batches daily.
- Participated in quality governance discussions and deviation review boards.
- Performed Raw Materials testing using GDP and GMP practices, using LIMS for documentation
- Supported SOP editing in MyCIMS.
Chemical Quality Lab Analyst II
Pfizer
Rocky Mount, NC
04.2021 - 03.2022
- Sterile Injectable Manufacturing
- Performed in-process and release testing for sterile injectable products.
- Analytical techniques included HPLC (Empower), UV-Vis (UV WinLab), ICP-MS (Syngistix) and wet chemistry assays.
- Initiated laboratory investigations in TrackWise for OOS and atypical results, maintained on-time closure.
- Supported product impact assessments and raw material disposition discussions.
- Reviewed logbooks for GMP compliance and deviation linkage.
- Ensured data integrity compliance with 21 CFR Part 11 and ALCOA+ principles.
Molecular Scientist
Mako Medical
Hendersonville, NC
10.2020 - 03.2021
- Performed PCR-based COVID-19 testing in a CAP-accredited lab, testing 300-450 samples per day.
- Ensured sample traceability, accurate documentation, and data integrity.
- Investigated atypical amplification curves and instrument flags.
- Reviewed instrument performance logs and calibration data.
- Maintained strict turnaround timelines in high-throughput environment.
Chemical Quality Lab Analyst I
Pfizer
Rocky Mount, NC
04.2019 - 10.2020
- Performed incoming material testing on primary packaging components and container systems, decreasing backlog by 45% over a 6 month period.
- Conducted dimensional and physical testing using calipers and analytical measurement tools.
- Executed analytical techniques supporting material qualification and release.
- Investigated material-related discrepancies and documented findings in GMP systems with 100% on-time closure.
- Reviewed batch documentation and ensured accurate LIMS data entry.
- Supported deviation investigations and technical report authoring.
Education
Bachelor of Science - Chemistry
Lander University
Greenwood, SC04-2012
Certificate - Understanding Validation
BioPharma Institute
Newark, NJDoctor of Pharmacy (PharmD) -
Duquesne University
Pittsburgh, PA04-2031
Skills
- OOS, Invalid Assay & Deviation Investigations
- Root Cause Analysis (5 Whys, Fishbone, Data Trending)
- CAPA Development & Effectiveness Checks
- Lot Disposition Support & Product Impact Assessment
- Data Integrity & ALCOA Compliance
- Audit Trail Review (Empower, LIMS)
- TrackWise Investigation & CAPA Ownership
- Veeva Vault Document Control & Workflow Creation
- GMP Compliance (21 CFR Part 11)
- Biologics & Sterile Manufacturing Support
- Quality management systems
Timeline
Quality Control Associate III
Biogen
08.2023 - Current
Quality Control Associate II
Biogen
03.2022 - 07.2023
Chemical Quality Lab Analyst II
Pfizer
04.2021 - 03.2022
Molecular Scientist
Mako Medical
10.2020 - 03.2021
Chemical Quality Lab Analyst I
Pfizer
04.2019 - 10.2020
Bachelor of Science - Chemistry
Lander University
Certificate - Understanding Validation
BioPharma Institute
Doctor of Pharmacy (PharmD) -
Duquesne University