Data Quality & Documentation Specialist

LISA JACOB

Macungie, PA • 570-***-**** • ***********@*****.***

PROFESSIONAL SUMMARY

Detail-oriented Data Quality & Documentation Specialist with 5+ years of experience in high-volume database administration, regulatory compliance, and quality operations. Proven expertise in data entry precision, system auditing, Good Documentation Practices (GDP), and root-cause error resolution across medical device, laboratory, and corporate environments. Adept at navigating complex database management systems (SAP, LIMS), maintaining 100% data integrity, and optimizing digital documentation workflows under strict operational timelines.

CORE SKILLS

Data Operations & Systems: SAP, LIMS, High-Volume Data Entry, MS Office (Advanced Excel VLOOKUPs, Word, PowerPoint), Electronic Document Management Systems (EDMS), Record Indexing & Archiving Quality & Regulatory Compliance: Data Verification & Auditing, Good Documentation Practices (GDP), FDA MDR, 21 CFR, ISO 13485, GMP Standards, Root-Cause Analysis, Trend Reporting Process & Operations: Complaint Triage & Intake Processing, Audit Support, Cross-Functional Team Mentorship, Customer & Vendor Liaison

PROFESSIONAL EXPERIENCE

Data Quality & Surveillance Specialist — B. Braun Medical Inc. May 2021 – Present Accurately ingest, triage, and process high volumes of post-market surveillance items and regulatory records into central databases, ensuring 100% adherence to strict timelines. Audit, maintain, and update critical surveillance records and databases; enforce Good Documentation Practices

(GDP) and eliminate data entry discrepancies.

Execute root-cause investigations and trend analyses on complex complaint data to identify operational risks and drive process improvements.

Prepare comprehensive regulatory adverse event data reports and cross-functionally present findings to internal stakeholders.

Assist in regulatory compliance audits by compiling, verifying, and delivering precise documentation and database records.

Quality Control & Systems Specialist — OraSure Technologies (Bethlehem, PA) May 2020 – Nov 2020 Utilized SAP enterprise software daily to input, maintain, and track precise data logs regarding testing schedules, resource utilization, and lot numbers.

Performed comprehensive quality inspection and data verification on incoming raw materials and finished medical devices.

Authored and maintained highly accurate quality documentation in strict compliance with cGMP standards and regulatory requirements.

Quality Documentation Specialist — Brenntag NA (Reading, PA) Sep 2019 – Jan 2020 Lisa Jacob — Resume Page 1 of 2

Managed the internal digital database of quality documentation, proactively auditing entries, purging expired files, and indexing new records for seamless retrieval.

Partnered in implementing a modernized digital filing system, significantly enhancing database retrieval speeds, ease of use, and overall data accuracy.

Processed and distributed high-precision compliance documentation for third-party customers, vendors, and sales teams.

Inside Sales / Lab Technician — Intertek Analytical (Allentown, PA) Jun 2013 – Aug 2019 Logged, structured, and managed client testing data programs, maintaining high standards of administrative organization and precision.

Operated complex analytical laboratory equipment to generate, verify, and document high-quality technical data. QC Lab Technician — Conagra Foods (Martin's Creek, PA) Aug 2010 – Jun 2013 Recorded detailed qualitative/quantitative data into electronic spreadsheets and manual logbooks, utilizing Excel for statistical analysis.

Prepared, reviewed, and issued formal Certificates of Analysis (COA) for outbound customer orders. EDUCATION & CERTIFICATIONS

A.A.S. Degree in Chemical Technology — Lehigh Carbon Community College (Dean's List, 3.2 GPA) Nationally Certified Pharmacy Technician — PTCB (Certified 2011) Lisa Jacob — Resume Page 2 of 2

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