Documentation and Training Specialist

JOB SUMMARY

The Quality Assurance (QA) Documentation and Training Specialist ensures that Batch Folder documentation is accurate and complete, in line with product requirements. This role also includes providing training to staff on documentation standards and procedures. The QA Documentation and Training Specialist will track and report trends in errors to the Director of QA Compliance, recommending corrective and preventative actions. In addition to documentation oversight, this position is responsible for training personnel to ensure compliance with established procedures and guidelines. The Documentation and Training Specialist has supervisory authority as it pertains to documentation and training compliance.

REPORTING RELATIONSHIPS

The following positions directly report to:

• Director of QA Compliance

DUTIES & ESSENTIAL JOB FUNCTIONS

• General duties involve:
• Verify that the documents in the issued Batch Folder align with the Master documents.
• Issue Batch Folder ancillary documentation.
• Receive Microbiology and Analytical QC approval documents.
• Perform final Batch Folder review and release for shipping.
• Log Batch Folder information on the QA office computer.
• Perform component reconciliation and investigate discrepancies in component item numbers.
• Send finished goods samples to customers who request them.
• Generate label return folders and CoA (Certificate of Analysis) and CoM (Certificate of Manufacturing) for customers when needed.
• Monitor and log any Batch Folder leaving the QA office.
• Act as a backup for initiating production Batch Folders.

· Training Responsibilities:

• Create training materials and resources to support staff understanding of QA documentation and compliance.
• Regularly assess the training needs of team members and provide ongoing educational support.
• Track and document training progress for employees, ensuring all team members are up to date on required certifications and procedural knowledge.
• Collaborate with the QA Management team to implement improvements in training based on error trends and compliance audits.

· Communication:

• Communicate all irregularities and areas of concern to the QA Management team.
• Ensure consistent feedback is provided to employees to improve documentation practices.

QUALIFICATIONS

• Effective communication and comprehension skills—verbal and written. Bilingual in English is a plus.
• Strong problem-solving skills.
• Ability to follow guidelines for professional behavior.
• Familiarity with GMP (Good Manufacturing Practices) concepts.
• Must possess initiative and be willing to remain flexible in a dynamic environment.
• Ability to work with minimal supervision.
• Strong organizational skills.
• Education and/or experience related to Quality Assurance, preferably in a Manufacturing/Production environment.
• Prior experience in training or documentation compliance is highly desired.

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

· Ability to sit at desk for long periods of time.

Job Type: Full-time

Pay: $40,000.00 - $60,000.00 per year

Benefits:

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

Schedule:

• 8 hour shift

Work Location: In person

Salary : $40,000 - $60,000