Do you want to work for one of the largest “Healthcare” company in Massachusetts? They are currently looking for an “Document Control Specialist” to support their facility in Marlborough, MA. If you’re interested and qualified, we urge you to apply!
The Project Document Control Specialist is responsible for accurate management and safeguarding of customer- facing product documentation generated by the hardware engineering project team in support of the day-to-day operation of the projects. This includes, but is not limited to, creating, editing or assembling product and project documents, operating procedures, manuals, engineering/technical reports and transmittal, correspondence and project management files. The Document Control Specialist must maintain minimum processing standards and meet deadlines by working in a high-pressure environment at a fast pace while maintaining quality and error free work.
- Work in cooperation with the project Technical Lead and create, revise, archive and manage product and engineering documents and templates in the document control system
- Document control and assembly of engineering documents on multiple simultaneous projects in support of operation (preparing electronic and/or paper copy of the product Turn Over Package (TOP))
- Produce and manage projects documentation status reports
- Assemble documents and manage customer design approval package submittals.
- Support Document Change Request (DCR) processes; word-process final version of new or revised documents for approval
- Support Engineering Change Orders (ECOs)
- Resolve documentation issues working in collaboration with technical staff and Quality Assurance
- Create new and revise existing SOPs, training guides, and checklists as necessary
- Ensure that all templates used by the department conform to the company quality standards
- Work within company’s Quality Management System
- Ad hoc duties are required to support project teams
SPECIFIC SKILLS REQUIRED
- In-depth understanding of multi-level Assembly and Sub-Assembly Bills of Material (BOM’s) and configuration management
- Working knowledge of Engineering Change Orders (ECO) and/or Engineering Change Request (ECR)
- Proficient in use of product data management systems
- Documentation, specification and test protocol creation and review
- Familiarity with bio-pharma industry, cGMP and regulated industry standards, guidelines and best practices
- Highly detailed-oriented with solid organization skills
- Ability to “figure things out,” understand workflows and suggest improvements
- Self-directed and motivated with ability to handle multiple tasks and synthesize disparate information
- Ability to prioritize and adapt quickly to changing needs
- Customer service oriented
- Performance driven with an understanding of how to work collaboratively with cross-functional teams
- Positive and enthusiastic attitude
- Experience with Technical Writing
- Excellent written and verbal communication skills required for documentation process.
EDUCATION AND EXPERIENCE:
- Education: Bachelor’s degree in business, engineering or a related discipline ~ or ~ 5 years of document control experience
- Experience: 3-5 years related experience in clerical, change control process management, administrative related disciplines
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Other: Computer skills required. Knowledge with Microsoft Office (Word, Excel, OneNote, Outlook), Adobe Acrobat.