Summary
Overview
Work History
Education
Skills
Additional Information
Timeline
BusinessDevelopmentManager
Erin O'Rourke

Erin O'Rourke

CMMS Administrator
Spokane,WA

Summary

Meticulous and methodical document management professional with over a decade of experience in contract manufacturing industries. A background in electronics and pharmaceuticals contributes to knowledge and expertise in industry and regulatory compliance including ESD, ISO9001, AS9100, GMP, ISPE, Annex 1, ISO 14644. Possesses a strong work ethic and a passion for cross-departmental collaboration.

Overview

12
12
years of professional experience
4
4
years of post-secondary education

Work History

CMMS Administrator

Selkirk Pharma
Spokane, WA
10.2024 - Current
  • Reduced downtime and maintenance costs by implementing preventive maintenance schedules for critical assets.
  • Wrote maintenance plans to bring contracted work in-house to save approximately $80,000.
  • Leads cross-departmental working sessions to review work orders, write maintenance plans, generate calibration worksheets, and strategize overall system policies and functionality.
  • Provides end-user support and escalates issues to vendor support.
  • Evaluates software upgrades and writes risk assessments.

Technical Documentation Specialist

Selkirk Pharma
Spokane, WA
10.2023 - 10.2024
  • Drove the completion of approximately 30 documents, including procedures, work instructions, and policies, prior to our first APS campaign. Championed this effort in three months.
  • Participated in document panels providing peer edits and reviewing for Good Manufacturing Practices and content.
  • Collaborated with Subject Matter Experts to establish operating procedures for critical assets in the facility.
  • Wrote written assessments and generated training plans to support document effectiveness.
  • Supported other departments with document needs including, but not limited to, authoring acceptance reports, writing administrative procedures, and overhauling manual training process.

Document Control Supervisor

BEMA Electronics, Inc.
4545 Cushing Parkway, Fremont, CA 94538
09.2013 - 10.2023
  • Evaluated current document processes, suggested methods for change and implemented successful improvements.
  • Managed technical documentation flow of engineering, project management and construction activities.
  • Carefully reviewed all documents and reports for completeness and accuracy.
  • Checked accuracy and completeness of documents to identify deficiencies and recommend corrective actions.
  • Maintained document archive and file server of approved documents and drawings to provide easy traceability and retrievability.
  • Oversaw creation, routing and data input of bills of materials, ECOs, ECRs and ISO documents.
  • Manipulated and converted documents to meet needs of individual personnel or projects.
  • Collaborated across departments and levels of management to gain consensus on procedural documentation.
  • Prepared documents for projects in accordance with project manager, team or client specifications.
  • Assisted in continuous improvement activities while developing and maintaining resulting documents.
  • Completed, configured and revised engineering change orders.
  • Established, improved and reinforced document management systems to handle current and expected requirements.

Education

Bachelor of Arts - Sociology

California State University - East Bay
Hayward, CA
01.2009 - 06.2013

Skills

Process development

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Additional Information

  • Willing to work remotely, hybrid or in an office setting.
  • Willing to learn new software or certifications to further my knowledge and expertise for the betterment of my employer.
  • A passionate employee with an exceedingly strong work ethic.

Timeline

CMMS Administrator

Selkirk Pharma
10.2024 - Current

Technical Documentation Specialist

Selkirk Pharma
10.2023 - 10.2024

Document Control Supervisor

BEMA Electronics, Inc.
09.2013 - 10.2023

Bachelor of Arts - Sociology

California State University - East Bay
01.2009 - 06.2013
Erin O'RourkeCMMS Administrator