"Alerted.org

JOB PURPOSE:

The Document Control Technician is responsible for maintaining and improving the company’s document control system to ensure organized, secure, and compliant documentation across the organization. This role plays a critical part in transitioning from a paper-based to an electronic Quality Management System (eQMS), supporting regulatory compliance and operational excellence. The technician will also coordinate training documentation, calibration records, and quality documentation to support internal stakeholders and external audits.

ESSENTIAL DUTIES:

• Coordinate with cross-functional departments to manage controlled documents, including standard operating procedures (SOPs), work instructions, labels, forms, and quality records.

• Lead the conversion of the current paper-based document control system to an electronic QMS platform; support activities up to and including system validation.

• Maintain up-to-date documentation at points of use to support production, ensuring only current, approved revisions are in circulation.

• Control document issuance, distribution, reviews, revision tracking, and archival in accordance with internal quality system requirements.

• Own and manage the site training matrix and ensure employee training records are current and aligned with the latest approved documents.

• Assist in the creation and formatting of quality documents and forms using Microsoft Word, Excel, and PowerPoint.

• Prepare customer-facing documentation such as Certificates of Conformance (CoC), inspection reports, and related quality documentation packages.

• Maintain calibration records and ensure equipment is calibrated on schedule without lapses; file certificates and update logs accordingly.

• Support ISO audits, customer audits, and internal inspections by retrieving and providing required documentation in a timely and accurate manner.

• Maintain vendor certification records and supplier documentation logs.

• Perform front-desk support functions including answering calls as needed.

• Ensure compliance with all SPG and DuPont safety policies and procedures.

• Process document change orders (DCOs) and maintain structured records for document revisions.

• Perform other administrative or document-related duties as assigned.

Qualifications

Required:

• High school diploma or equivalent.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Experience working within an electronic QMS and ERP environment (IQMS preferred).

• Strong organizational skills and attention to detail.

• Ability to identify discrepancies and proactively resolve issues with minimal supervision.

• Excellent written and verbal communication skills.

• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.

• Understanding of document control practices in a regulated manufacturing or quality system environment.

Preferred:

• Associate degree or relevant certification in Document Management, Quality, or a related field.

• 3–5 years of experience in document control, preferably in a regulated industry (medical device, pharmaceutical, or manufacturing).

• Familiarity with ISO 13485 documentation requirements.

• Experience supporting internal or third-party audits.

WORKING CONDITIONS:

This is primarily an office-based position with the majority of time spent at a computer workstation. Some interactions with production and quality personnel in a manufacturing environment are expected. Occasional lifting of document files or archive boxes may be required.