Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
25
25
years of professional experience
1
1
Certification
Work History
QA & Compliance Auditor
Camfil USA
03.2011 - Current
Collaborated with cross-functional teams to ensure timely implementation of corrective actions, mitigating potential compliance issues.
Analyzed all audit results and resolved all compliance issues.
Maintained up-to-date knowledge of regulatory changes affecting the business landscape, proactively adapting audit strategies as needed.
Performed over 12 compliance audits per month.
Host Customer Audits such as DOE, cGMP, Military, Factory Mutual, NQA-1, and ISO 9001
Monitored customer complaints and assist with RCCA
Participated in various training and development programs.
Partnered with auditors to track errors and add contributions to maintain accuracy.
Trained new employees on company procedures.
Supervise a group of 6 employees.
Acting Quality Manager for nine years.
Receiving Inspector
Camfil USA
09.2006 - Current
Demonstrated adaptability when faced with changes in shipment schedules or priorities, adjusting plans accordingly to maintain overall efficiency levels throughout the receiving process.
Enhanced inspection efficiency by streamlining the receiving process and implementing new protocols.
Supported continuous improvement initiatives by offering valuable insights into potential areas for improvement within the receiving process.
Collaborated with purchasing department to resolve any issues regarding delayed shipments, maintaining clear communication lines.
Reviewed incoming shipments for correctness to ensuring no damage or duplication of orders.
Quality Assurance Inspector
Catalent Pharma Solutions
03.2011 - 04.2012
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.
Communicated with production team members about quality issues.
Used calipers and micrometer measuring instruments.
Performed room closeout accountability for all raw materials.
Quality Control Technician
Camfil USA
02.2007 - 01.2011
Maintained quality documentation and records for conformance with relevant standards.
Collaborated with production teams to address and resolve quality concerns, improving overall product reliability.
Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
Enhanced product quality by conducting comprehensive inspections and identifying defects in a timely manner.
Maintained accurate records of all quality control activities, ensuring easy retrieval for audits or management inquiries.
Proposed corrective actions to address recurring quality issues.
Trained new team members on proper quality control techniques, fostering a culture of excellence within the department.
Helped uncover and fix production problems in order to reduce overall defect rates.
Assisted management in maintaining ISO certification through diligent documentation and adherence to established protocols.
Managed non-conforming product evaluations and disposition, minimizing negative impacts on production schedules and customer satisfaction.
Led root cause analysis to identify issues and propose targeted solutions.
Reviewed production processes and identified potential quality issues.
Inspected items and compared them against standards to meet regulatory requirements.
Document Control Specialist
Blistech
07.1999 - 10.2004
Maintained version control for all documents, ensuring that only the most recent updates were in circulation at any given time.
Maintained document control system and updated work instructions, procedures and associated databases.
Provided assistance with inbound and outbound document processes, document sorting, logging, and work order creation.
Facilitated timely project completion by managing the distribution of essential documentation to project team members.
Education
GED -
State of New Jersey
Paterson, NJ
12.2004
Certificate - Clinical Medical Assistance
Institute For Allied Medical Technology
New York, NY
01.1998
Skills
Strong computer skills
Software Knowledge
Regulatory knowledge
Auditing experience
Audit Planning
Internal controls evaluation
Attention to Detail
Clear Communication
Team Collaboration
Decision-Making
Relationship Building
Documentation and Reports
Employee Training
Document Recordkeeping
Staff Training
Compliance Reporting
Records Review
Audit Support
Certification
Classroom Sessions:
Certified Lead Auditor ISO 9001:2015
Nuclear QA-1 Lead Auditor
OSHA Hazard Communication Training,
Simulation Fire Training in Handling Portable Fire Extinguisher
Excel 2003 and 2007 Level 1
Excel 2003 and 2007 Level 2
Security Awareness Foundations
Micro-module-Introduction to Ransomware
KnowBe4 Pretexting-"Fake It" Password Break-In
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
QA & Compliance Auditor
Camfil USA
03.2011 - Current
Quality Assurance Inspector
Catalent Pharma Solutions
03.2011 - 04.2012
Quality Control Technician
Camfil USA
02.2007 - 01.2011
Receiving Inspector
Camfil USA
09.2006 - Current
Document Control Specialist
Blistech
07.1999 - 10.2004
GED -
State of New Jersey
Certificate - Clinical Medical Assistance
Institute For Allied Medical Technology
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