Summary
Overview
Work History
Education
Skills
Professional Development
Professional Highlights
References
Languages
Timeline
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BEVERLEY MOULTON

Brampton,ON

Summary

Quality Assurance Specialist with 20+ years of document reviewing experience in the Pharmaceutical GMP industry. Proficient in Microsoft Word formatting and sharepoint document management system. Familiar and comfortable with QA/QC paper-based document control procedures in addition to the LIMS computer regulated environment. Excellent eye for detail and highly organized.

Overview

24
24
years of professional experience

Work History

QA Document Reviewer

ARA Avantirx
01.2019 - 01.2022
  • Reviewed analytical reports submitted by R&D, QC Laboratory and Production for accuracy and completeness ensuring compliance with GLPs, GMPs, ARA SOPs and other Regulatory requirements
  • Reviewed IQ/OQ/PQ, PM and Calibration reports on various Laboratory equipment
  • Supported the SOP system including drafting, assigning SOP numbers and making SOP effective
  • Assigned Stability Protocol numbers and stability numbers to samples destined for Stability studies
  • Acted as a QA Designate issuing CCRs/DRs/CAPA/TARs, communicating the status to each department ensuring timely closure and to perform trending based on matrix
  • Reviewed, participated in drafting, and approval of quality documentation such as Change Controls, Deviations, CAPAs and TARs
  • Compiles Laboratory records for release, ensuring all information have been reviewed and any issues resolved
  • Reviews and approves production related documentation such as master batch records, executed batch records, logbooks and SOPs.
  • Assisted in creating and maintaining internal Access databases supporting office's internal processes.
  • Analyzed available information and data to inform audit review process.
  • Collaborated with cross-functional teams to achieve project goals within tight deadlines.
  • Applied advanced knowledge of QA/QC terminology when reviewing manufacturing, QA/QC and other related documentation results.
  • Trained new hires on document review software and protocols, fostering a supportive learning environment.
  • Maintained clear lines of communication with Supervisors regarding progress updates and any challenges faced during the review process.
  • Managed multiple simultaneous projects, demonstrating strong multitasking skills while maintaining high-quality results.
  • Managed file archival and information retrievals.

Quality Control Lab Technologist

Purdue Pharma
01.2003 - 01.2019
  • Co-ordinated and maintained the Stability Program for products generated
  • Monitors Stability Chambers ensuring operation at specified conditions.

Quality Control Lab Technologist

Purdue Pharma
01.2003 - 01.2019
  • Reviews all technical stability document generated by chemist ensuring accurate and concise reporting of test results
  • Maintains an accurate database of all stability data based on products, provides trend analysis on OOS and OOT results as well as shelf life extensions on a timely basis
  • Performs on-line inspections of packaged goods ensuring that Quality Standards of the Company are within specifications
  • Modified existing Standard Operating Procedures and reviewed Stability Protocols.

Quality Assurance Technician

Bayer Canada Inc
01.2001 - 01.2003
  • Reviewed reports generated by chemists ensuring that products were tested according to the required test methods with the use of GC, HPLC, UV, FTIR to determine the required attribute of the product
  • Prepared volumetric and test solutions as per USP Pharmacopeia
  • Wrote complete and concise technical report based on product tested, confirming that the product is within the required specifications.

Laboratory Technician

Revlon Canada
01.1998 - 01.2001
  • Maintained and calibrated the laboratory equipment as required
  • Performed GMP and GLP audits on monthly basis; assesses findings and wrote technical report to each departments on non compliance issues
  • Released raw materials and finished goods on AS400 system
  • Performed environmental monitoring of Manufacturing and Packaging departments on a monthly basis
  • Prepared Drug Submission Forms for various products as required obtaining DIN
  • Modified and updated Standard Operating Procedures to reflect current practices
  • Provided safety training for employees on a monthly basis.

Education

Good Manufacturing Practices Certificate - QA/QC

AAPS
Brampton, ON
12.2021

Computer Application Programming and System Analysis -

Toronto School of Business
Toronto, Ontario
12.1997

Bachelor Degree in Chemical Engineering -

Ryerson Polytechnic University
Toronto, Ontario
12.1996

Skills

  • Data entry proficiency
  • QA/QC knowledge
  • Accuracy and Precision
  • Document review abilities
  • Problem-Solving
  • Teamwork and Collaboration
  • Time Management
  • Multitasking Abilities
  • Effective Communication
  • Interpersonal Communication
  • Analytical Skills

Professional Development

  • Empower Training –Custom Fields, Mississauga, Ontario, 2010-01-01
  • Statistic Analysis, Toronto, Ontario, 2007-01-01
  • Stability Training, Toronto, Ontario, 2006-01-01
  • Microbial Analysis, Edison, New Jersey, 1998-01-01
  • GMP and Environmental Analysis, Phoenix, Arizona, 1998-01-01

Professional Highlights

  • Committed to professional excellence, extensive knowledge of laboratory practices including cGMP and GLP
  • Solid background knowledge and skills in Laboratory instrumentation including HPLC, Dissolution, UV and KF
  • Use of the USP Pharmacopeia and Standard Operating Procedures in the analysis of a Drug Product
  • Skilled in the Document reviewing process of technical reports generated by Chemists
  • Exceptional written and verbal communication capabilities combined with excellent coordinating skills
  • Ability to determine the shelf life of a product based on RT and accelerated Stability data with the use of statistical software
  • Excellent computers knowledge including: Word/Excel, LIMS
  • Excellent time management skills; effective at prioritizing tasks to meet assigned deadlines
  • A productive and inclusive team player who is able to succeed in challenging and diverse work environments
  • Enjoys working in a challenging environment; proven multitasking abilities and demonstrated problem solving skills

References

Available Upon Request

Languages

English
Full Professional

Timeline

QA Document Reviewer

ARA Avantirx
01.2019 - 01.2022

Quality Control Lab Technologist

Purdue Pharma
01.2003 - 01.2019

Quality Control Lab Technologist

Purdue Pharma
01.2003 - 01.2019

Quality Assurance Technician

Bayer Canada Inc
01.2001 - 01.2003

Laboratory Technician

Revlon Canada
01.1998 - 01.2001

Good Manufacturing Practices Certificate - QA/QC

AAPS

Computer Application Programming and System Analysis -

Toronto School of Business

Bachelor Degree in Chemical Engineering -

Ryerson Polytechnic University
BEVERLEY MOULTON