Senior QA Specialist Resume Example

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SENIOR QA SPECIALIST
Summary
Professional experience in Quality Assurance and Compliance environment and regulations within pharmaceutical products industry.  Strong skills as a Quality Auditor, Cleaning Validation, Compliance Investigator and Complaints management system.  
Experience
Senior QA SpecialistOct 2013 to Current
Company NameCity, State
Advisor and approver of pharmaceuticals operations by means of the following QA related activities:
  • Complaint Management System Administrator
  • QA support to the Engineering and Supply Chain areas
  • Support to Quality Control laboratory systems
  • Operation Change Management (Change Controls) 
  • Internal and external QA audits
  • Cleaning and Process Validation approvals and support
  • Computer Validation
  • Equipment Qualifications
  • Performing Compliance investigations
  • Standard Operating Procedures
  • Vendor and Supplier management
  • Complaints investigations approval
  • CAPAs approval
  • Deviations approval
  • Batches disposition
Pharmaceutical TechnologistFeb 2013 to Oct 2013
Company NameCity, State
As a Pharmaceutical Technologist, support activities related to Cleaning Validations performing:
  • Holding Time studies in manufacturing equipment
  • generation of Cleaning Validation protocols and reports
  • Cleaning Validation annual monitoring and reporting
Compliance OfficerDec 2010 to Jan 2013
Company NameCity, State

Advisor and approver of pharmaceuticals operations by means of the following QA related activities:

  • Complaint Management System Administrator
  • QA support to the Engineering and Supply Chain areas
  • Support to Quality Control laboratory systems
  • Operation Change Management (Change Controls) 
  • Internal and external QA audits
  • Cleaning and Process Validation
  • Computer Validation
  • Equipment Qualifications
  • Performing Compliance investigations
  • Standard Operating Procedures
  • Vendor and Supplier management    
Compliance InvestigatorJan 2006 to Dec 2010
Company NameCity, State
  • Conduct in-depth investigations of product related failures events
  • Generate a well-balanced reports of the investigation process, assuring accuracy and integrity of the data
  • Investigate Internal and External Complaints 
  • Evaluate and approve deviations reports
  • Provide coaching/training to peers in investigation techniques and technical writing skills
  • As a temporary assignment, coordinate team investigations activities
QA System AdvisorSep 2003 to Dec 2005
Company NameCity, State
  • Certified by the ASQ as a Quality Auditor, performed internal audits
  • Reporting the Quality and Compliance metrics (Key Performance Indicators) to the IPR Senior Management and Directors.
  • Complaints Management system administrator
Analytical Development Group ChemistDec 2000 to Sep 2003
Company NameCity, State

As a Chemist, responsible for the following activities related to Analytical Methods validation:

  • Issuance of Cleaning Validations protocols for Detergents
  • Cleaning Analytical Methods execution and reporting
Laboratory ChemistDec 1999 to Dec 2000
Company NameCity, State
Responsible for the laboratory start-up of the new manufacturing facility of MOVA Pharmaceuticals with the following reponsibilities:
  • Equipment qualifications (protocols, executions and reporting)
  • Issuance of Standard Operating Procedures
  • Cleaning Validation monitoring of manufacturing equipment
  • Cleaning validation samples analysis


Chemist IIOct 1998 to Dec 1999
Company NameCity, State
Perform Raw Material testing by means of applicable Pharmacopeias and internal methodology. (1998) 
Team Leader coordinator of the Method Transfer and Analytical Method Validation Team (1998-1999):
  • Cleaning Analytical Method Validation
  • Cleaning Analytical Method Transfer
  • Protocols generation, execution and reporting
Laboratory AnalystSep 1996 to Oct 1998
Company NameCity, State
Support to the Raw Material testing by means of applicable Pharmacopeias and internal methodology. (1996)
Within the Method Transfer and Analytical Method Validation Team (1996-1998), reponsible for the following activites:
  • Cleaning Analytical Method Development
  • Cleaning Analytical Method Validation
  • Cleaning Analytical Method Transfer
  • Protocols generation, execution and reporting
Laboratory AnalystJul 1994 to Aug 1996
Company NameCity, State
  • Perform within a start-up team, the new facility (PR3) equipment qualifications activities
  • Finish product full testing and reporting for product suspensions dosage form
Education
Bachelor of Science, Chemistry1995Interamerican UniversityCity, State
Chemistry1993University of MassachussetsCity, State, US
Pre-Medical Technology1986Universidad de Puerto RicoCity, State
Other trainings and certifications AZ-Doc System, AZ-Learn System, The 7 Habits of Highly Effective People, Leadership Capabilities, World Class Manufacturing, Project Management, Lean Tools (Visual Management, Problem Solving, Standard Work, 5S, Root Cause Analysis, Global Operation Change Management System, Trackwise – GMP Investigations & CAPAs System, GCM – Global Complaint Management System, LDMS- Lightweight Document Management System, Validation/Qualification of Laboratory, Manufacturing and Computer Systems or Equipments/Instruments, GMP Compliance Auditing, Technical Writing Skills, Cleaning Validation, Basics Statistical Training, ASQ Certified Quality Engineering, ASQ Certified Quality Auditor, CAPA Management

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Resume Overview

School Attended

  • Interamerican University
  • University of Massachussets
  • Universidad de Puerto Rico
  • Other trainings and certifications

Job Titles Held:

  • Senior QA Specialist
  • Pharmaceutical Technologist
  • Compliance Officer
  • Compliance Investigator
  • QA System Advisor
  • Analytical Development Group Chemist
  • Laboratory Chemist
  • Chemist II
  • Laboratory Analyst

Degrees

  • Bachelor of Science , Chemistry 1995
    Chemistry 1993
    Pre-Medical Technology 1986

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