Engineering Documentation Specialist Associate

Yoh has a long term contract opportunity for an ENGINEERING DOCUMENTATION SPECIALIST ASSOCIATE to join our client, a world leader in the consumer goods industry, located in ALLSTON, MA.

JOB RESPONSIBILITIES:
- Handles documentation for multiple projects concurrently and in an organized fashion
- Assigns document numbers to engineering documentation
- Registers new engineering documents and their revisions into the Master Record Index (MRI) Maintains a secure working and document storage environment
- Maintains structured document libraries
- Assists clients to locate engineering documents and drawings and produces official copies
- Inventories, categorizes and archives Legacy engineering documentation
- Digitizes hard-copy documents
- Performs documentation reviews to ensure compliance with site, corporate and regulatory requirements and controls compliant documentation in accordance with site procedures
- Participates in engineering documentation projects, reporting task progress and adhering to schedule deadlines for on-time delivery
- Acts as engineering documentation subject matter expert (SME), as appropriate to role, in cross-functional project teams
- Assists in closure of quality events, as appropriate to role
- Provides support to project teams as an engineering documentation business partner, including documentation review, coordination of engineering turnover package (ETOP) receipt and other engineering documentation system support, as required
- Participates in area self-inspections and ensures the system is maintained in an audit-ready state
- Interacts with site QA to support internal and external regulatory CGMP inspections, audits and consent decree verifications
- Interacts with other functional groups at quality system interfaces and in support of daily site operational success

JOB QUALIFICATIONS:
- High school diploma and at least one (1) year significant experience in engineering project work in design, commissioning and validation, in a biotech or similar manufacturing arena
- Experience with Current Good Manufacturing Practices (CGMP), Good Documentation Practices (GDP) and other applicable regulatory requirements

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Natane Peslis

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company. If you are seeking workforce solutions in the IT sector, see our comprehensive IT Staffing Resources .

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