OVERVIEW

We are seeking a detail-oriented and organized Document Control Specialist to join our team. The position combines the responsibilities of a document control specialist and a technical writer, ensuring efficient management of company documentation while also creating clear and comprehensive technical content. The ideal candidate will be responsible for organizing, storing, distributing various documents, enforcing quality standards, and developing user-friendly technical materials such as Standard Operating Procedures and work instruction forms. Must also have a strong understanding of quality management systems and document management practices, particularly within regulated environments such as ISO 9001, GMP, FDA 21 CFR Part 11, etc. The Document Control Specialist will play a key role in ensuring that all documentation is accurate, accessible, and up-to-date.

SKILLS

• Proficiency in ISO9001, ISO13485, cGMP/FDA standards related to quality management.
• Strong experience with document management systems and filing processes.
• Excellent organizational skills with a keen attention to detail.
• Proven ability in proofreading for grammatical accuracy and clarity.
• Proficiency with document management systems and tools is preferred.
• Strong understanding of documentation best practices, version control, and document lifecycles.
• Excellent written and verbal communication skills, including the ability to simplify complex information for a diverse audience. Exceptional attention to detail and organizational skills. Ability to work both independently and collaboratively in a team environment.
• Strong research, analytical, and problem-solving skills.

EDUCATIONAL REQUIREMENTS:

• Associate degree in a relevant field such as Technical Writing, Communications, Information Management,.
• 2+ years of experience in document control, records management, or technical writing, preferably in a regulated environment (ISO9001, ISO13485, cGMP/FDA).
  Job Type: Full-time
  Pay: $22.00 - $31.00 per hour
  Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In perso

• Implement and maintain document control procedures according to company policy and industry regulations.
• Organize and maintain both physical and digital documentation, including controlled documents, standard operating procedures, forms, labels, product master records and product manufacturing records.
• Manage the document lifecycle from creation to archival, ensuring accuracy, completeness, and version control.
• Maintain and manage the document control system.
• Ensure compliance with regulatory requirements (e.g., ISO 9001, GMP, FDA 21 CFR Part 11, etc.).
• Distribute documents to appropriate personnel and manage access control for sensitive or confidential information. Prepare documentation packages for audits and compliance reviews.
• Collaborate with department managers and other staff to write, review, and edit new controlled documents.
• Review and edit controlled documents submitted for revision by various departments.
• Manage the document review and approval process, track the location of the files being circulated for approval.
• Ability to multi-task.
• Other duties as assigned.