Leilanie Ostolaza
Perkasie,PA
Summary
Detail-driven Compliance Officer focused on maximizing company compliance with applicable laws and standards. Knowledgeable about internal controls, process evaluations and procedural reviews. Bringing ten years of experience in Quality and Pharmaceutical Industry.
Overview
10
10
years of professional experience
Work History
Customs & Compliance Officer
Almac Clinical Services
01.2020 - Current
- Developed and maintained compliance database, tracking all compliance activities and documents.
- Assisted with internal and external audits to confirm compliance with applicable laws and regulations.
- Conducted periodic compliance audits and reviews to identify areas of improvement.
- Collaborated with internal and external stakeholders, auditors and legal counsel to confirm compliance with applicable laws and regulations.
- Determined licensing or permits for importation needed by examining and comparing against established structures.
Quality Control Inspector
Almac Clinical Services
12.2015 - 12.2019
- Inspected incoming and outgoing materials for accuracy and quality.
- Communicated with production team members about quality issues.
- Inspected quality of products, taking note of functionality, appearance and other specifications.
- Performed visual inspections and non-destructive tests where appropriate.
- Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
Quality Control Inspector
American Pride Fasteners
08.2013 - 08.2015
- Evaluated components and final products against quality standards and manufacturing specifications.
- Inspected incoming and outgoing materials for accuracy and quality.
- Performed root cause analysis to identify and resolve defects, improving quality standards.
- Trained and mentored inspection staff best practices and comply with quality control guidelines and regulations.
- Sampled products to verify compliance with standards ISO9008
Education
BBA - Human Resources Management
DeSales University
Center Valley, PABBA - Marketing
Sistema Universitario Ana G Mendez - Universidad Del Este
Carolina, PRSkills
- Auditing Processes
- Training and Presentations
- Industry Trend Assessments
- Risk Management
- Internal Controls
- Document Review
- Regulations Enforcement
- Federal and State Regulations
- SOP Development
- Compliance Training
- Quality Control
Languages
English
Full Professional
Spanish
Native or Bilingual
Timeline
Customs & Compliance Officer
Almac Clinical Services
01.2020 - Current
Quality Control Inspector
Almac Clinical Services
12.2015 - 12.2019
Quality Control Inspector
American Pride Fasteners
08.2013 - 08.2015
BBA - Human Resources Management
DeSales University
BBA - Marketing
Sistema Universitario Ana G Mendez - Universidad Del Este
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