Documentation Control Clerk - Shift B

SUMMARY:

The Documentation Control Clerk is responsible for reviewing, controlling, and processing quality system documentation to ensure compliance with established document control procedures and quality requirements. This position supports the document lifecycle process, including document review, training assignment coordination, release activities, and maintenance of controlled records. The role requires strong attention to detail, strong computer skills, and the ability to work in a fast-paced, highly regulated environment while supporting multiple global sites.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Review submitted documents to ensure compliance with document control procedures, work instructions, and quality system requirements prior to approval and release.

• Process and maintain documentation throughout its lifecycle, including document review, approval routing, training assignment, and final release activities.

• Ensure document control activities are completed within established timelines and service level expectations.

• Coordinate training assignments and maintain training records for new and revised controlled documents.

• Verify that only the most current approved revision of documentation is available within the quality system.

• Execute documentation control activities including document review, auditing, record maintenance, document tracking, scanning and distribution of controlled documents.

• Coordinate documentation flow between internal departments, global sites and external service providers when required.

• Support Quality System audits and compliance activities, including documentation reviews, training audits, GMP compliance checks and record audits.

• Support document-related requests from Costa Rica and other global Confluent locations.

• Perform additional duties within the Quality organization as assigned.

EDUCATION and/or EXPERIENCE:

• High school diploma required. Technical degree or ongoing university studies are preferred.

• Minimum of 2 years of experience in documentation review, records management, administrative support, customer service, quality systems, logistics, clerk positions, document processing, or related functions.

• Experience handling controlled documentation, reviewing records, validating information, processing transactions, or supporting compliance-related processes is highly desirable.

• Medical device industry experience is preferred but not required.

• Intermediate English proficiency (B1 minimum) with the ability to read, understand, compare and interpret documentation in English and Spanish. Ability to communicate effectively in English in a business environment is preferred.

• Strong computer skills including Microsoft Word, Excel, Outlook and PowerPoint. Candidates must be comfortable working extensively with digital systems, document comparison tools and databases.

OTHER SKILLS AND ABILITIES:

• Exceptional attention to detail.

• Strong organizational and time management skills.

• Ability to review documentation and identify inconsistencies, discrepancies or missing information.

• Ability to work with multiple systems and manage a high volume of documentation.

• Strong written and verbal communication skills.

• Ability to understand and apply document control procedures, work instructions and quality system requirements.

• Ability to independently prioritize and manage multiple assignments in a fast-paced environment.

• Ability to learn and work within regulated environments, including Quality Systems and GMP requirements.

• Customer service mindset and ability to support internal stakeholders across multiple departments and global locations.