Document Control Specialist

Description

The Document Controller is responsible for maintaining and controlling company documentations, following and improving document control procedures to support the Quality Management System.

Responsibilities

• Develop and maintain document control procedures to ensure efficient and effective management of manufacturing documents.
• Create, review, edit, update, sort, store and retrieve electronic and hard copy documents for accuracy, completeness, and adherence to established requirements and standards.
• Oversee the creation, revision, distribution, and archiving of manufacturing documents such as standard operating procedures (SOPs), work instructions, batch records, and specifications.
• Monitor document access and security to maintain confidentiality and integrity.
• Work with stockholders to improve document control procedure.
• Provide training and guidance to employees on document control procedures and systems.
• Conduct regular reviews and document audits.
• Manage document change control process, including initiating change requests, coordinating reviews, and implementing approved changes.
• Assist quality management system including but not limit internal and external audit, continuous improvement, data analysis, management review.
• Stay updated on industry best practices and regulatory requirements related to document control in a manufacturing environment.
• Assist in office management, perform other office duties as assigned.

Qualifications and Experience

• Bachelor's degree in a related field or equivalent work experience.
• Proven experience in document control, preferably within a manufacturing environment.
• Proficiency in document control software and electronic document management systems.
• Fluency in the English and Chinese is preferred.
• Familiar with ISO9001 quality management knowledge.
• Strong analytical and problem-solving skills.
• Proficient typing and editing skills.
• Data organization skills.
• Attention to detail.
• Must be able to work with little supervision, must be self-directed.
• Computer literacy, including effective working skills with MS Office and e-mail required.