Job Description:

The Quality Assurance Documentation Specialist plays a vital role in ensuring compliance with quality standards and regulatory requirements within an organization. They are responsible for creating, maintaining, and organizing documentation related to quality assurance processes and procedures. The primary objective of this role is to ensure that all quality-related activities are properly documented, reviewed, and updated as necessary to support efficient and effective quality assurance operations.

Responsibilities:

Document Creation and Maintenance:

Develop, review, and update quality assurance documents, including standard operating procedures (SOPs), work instructions, quality manuals, and forms.

Collaborate with cross-functional teams to gather necessary information and ensure accuracy and completeness of documentation.

Ensure that all documents are properly formatted, organized, and version-controlled.

Regularly review and revise existing documents to align with evolving quality standards and regulatory requirements.

Compliance and Audit Support:

Assist in preparing for internal and external audits by ensuring all relevant documentation is up to date and readily accessible.

Participate in audits and inspections, providing documentation as requested and addressing any findings or non-compliance issues.

Collaborate with quality assurance teams to develop corrective action plans based on audit findings and monitor their implementation.

Process Improvement:

Identify opportunities for process improvement within the quality assurance department.

Analyze existing documentation and propose updates or modifications to enhance clarity, consistency, and efficiency.

Work closely with stakeholders to streamline document review and approval processes.

Training and Communication:

Develop training materials and conduct training sessions for employees on quality assurance processes and documentation requirements.

Communicate changes and updates to documentation to relevant stakeholders and ensure understanding and compliance.

Documentation Control:

Establish and maintain a comprehensive document control system, including document tracking, archiving, and retrieval.

Ensure that all documentation adheres to relevant regulatory standards and internal quality requirements.

Manage document workflows, including review, approval, and revision processes.

Qualifications:

Bachelor's degree in a relevant field (such as Quality Management, Life Sciences, Engineering) or equivalent work experience.

Proven experience in quality assurance documentation management within a regulated industry

Strong understanding of quality management systems (e.g., ISO 9001, cGMP) and regulatory requirements (e.g., FDA, EMA).

Excellent attention to detail and organizational skills.

Proficient in document control and management software.

Ability to effectively communicate and collaborate with cross-functional teams.

Strong analytical and problem-solving skills.

Familiarity with process improvement methodologies.

As a Quality Assurance Documentation Specialist, you will contribute to maintaining and enhancing the quality standards of the organization. Your attention to detail and expertise in documentation management will be critical in ensuring compliance with regulations and facilitating continuous improvement in quality assurance processes.

Job Type: Full-time

Pay: $15.00 - $22.00 per hour

Expected hours: 40 per week

Benefits:

• Paid time off

Experience level:

• 1 year

Schedule:

• Monday to Friday

Work setting:

• Assembly line
• In-person
• Manufacturing facility
• Office
• Warehouse

Language:

• English (Preferred)

Work Location: In person