EXPERTISE | COLLABORATION | DEDICATION | INNOVATION
At Integra, we leverage our innovative designs and integrated approach honed over the past decade combined with our relentless passion to mitigate risk, compress the schedule, reduce costs, and close the gap between capex and revenue generation as if we were building our own data center.
Our commitment to excellence drives our projects, and we seek a Document Control Specialist to join our growing team of leading-edge professionals.
POSITION OVERVIEW:
Reporting to the Quality Control Manager, the Document Control Specialist will be responsible for providing customer service and training to all employees needing assistance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
KEY RESPONSIBILITIES:
Administers document system access and revision control to ensure appropriate security based on business need
Assists with the assessment, acquisition and/or deployment of electronic document management systems
Assists in the development of document classifications to facilitate information storage and retrieval
Assist managers and others in creating training curricula, materials, documentation
Provide additional support to the Quality organization as required including maintaining original Quality documents, loading PDFs into the Quality SharePoint, updating controlled lists
Participating in planning, and successful implementation of special requests made by Manager/Project Managers including special information needs such as the need to extract information from documents extracts list of project materials and provides to engineering
Receive, file, and maintain all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, Product Complaints, computer system validation
Manage a Document Repository that tracks the receipt, revisions and archiving of all documents
Oversee and administer document lifecycle management the Document Change Request process
Assist in the maintenance of training records and documentation within our Learning Management System
Index of drawings
Provides support to the technical service teams in support of technical data integrity and entry
Work with Engineers to update Top Level BOM/Specification data in Cost Point
Maintain approval process
Schedule meetings with support teams to finalize BOM and/or RFP's
Responsible for the maintenance of the document control system
Maintains all ISO standard operating procedures, work instructions and product labeling files
Maintains revision and approval status of all documents
Maintains hard copies of all approved documentation
Perform special projects in Excel and other applicable software
Review of documentation – test results for raw materials, components and QA inspection documentation to assure material meets specifications
Reprocessing Approvals, Planned Deviations, Document Change Requests, Change Control Requests, templates
Ensure adherence with GMPs and SOPs
Balances personal work and team priorities
Respond to and resolve customer questions or issues
Compile reports, updating and verifying data for processing
Downloading drawings from the drawing list and save them to an electronic storage location specified General office skills (data entry, scanning documents, filing) are essential
Experience with MRP/ERP/PLM Systems is a plus
Must be a team player and interface well with others
Applied technical knowledge of Product Life Management systems is preferred
Manage the lifecycle of vendor documentation from receipt, distribute, review and return to vendor till compilation of final documentation
QUALIFICATIONS:
Education:
Post-Secondary education.
Experience:
3 years' experience in Document Control/QA/QC
These experiences should be gained in areas of engineering, quality or technical operations and should include a minimum of one year document control management
Experience in document control for the design and construction of large projects a plus
Experience with an electronic Quality/Document Management System preferred
Good organizational, project management skills and ability to perform varied tasks in a disciplined, consistent manner
Ability to analyze, interpret technical procedures and regulations
Quality Assurance experience in the industry, including the ability to identify and resolve document control and training compliance issues
Problem solver and ability to deal with a variety of concrete variables in situations where only limited standardization exists
Familiarity with the Engineering Release and Change Control process is a preferred
ISO experience is preferred
Good PC Skills. Proficiency with Microsoft Office applications.
Detail-oriented with a keen eye for precision, spotting errors and inconsistencies.
Ability to manage your time and deadlines, the ability to adapt to the ever-changing priorities of the market situation.
WE OFFER:
A DYNAMIC WORKPLACE: Join an innovative culture that encourages creativity and collaboration with a focus on results.
COMPETITIVE COMPENSATION: Competitive salary, including bonus eligibility, and a comprehensive total rewards package.
COMPREHENSIVE HEALTH BENEFITS: Access to medical, dental, and vision insurance to keep you and your family healthy.
SECURE YOUR FUTURE: Benefit from our 401(k)-retirement investment plan to help you achieve your long-term financial goals.
INVEST IN YOURSELF: Take advantage of ongoing professional development opportunities that foster career growth and advancement.
Integra is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.