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
Valor Documentation Preparation Software
Project and team support
Manage multiple client projects and data
Ability to meet highly fluctuating deadlines
Asset management
System configuration
GMP knowledge
Technical writing
Software evaluation
Change management
Continuous improvement
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