Clerk, Quality Records (Temp to Hire)

Job Title: Clerk, Quality Records

• Clerk I, Quality Records
• Clerk II, Quality Records
• Clerk III, Quality Records

Role Level: Individual Contributor (IC)

Supervisor/Manager Title: Supervisor, Quality Control.

Job Location & Environment: Irvine, California, Corporate Office & Cleanroom Manufacturing Area

Job Description Summary: Duties and responsibilities include providing administrative support for the Quality Department to ensure efficient product release for the Irvine production facility. Responsible for reviewing, completing, and archiving product DHRs and other applicable forms.

Job Responsibilities:

• Review Device History Records (DHRs), forms, logs, and other quality records for completeness, accuracy, and compliance with Good Documentation Practices (GDP).
• Identify missing, incomplete, or incorrect documentation and coordinate follow-up with the appropriate departments to ensure timely resolution.
• Scan, file, organize, and archive quality records in accordance with internal procedures and record retention requirements.
• Maintain documentation in a compliant and readily retrievable manner, both in physical and electronic systems.
• Support document control and records management activities within the Quality Department.
• Assist with the preparation, compilation, and organization of quality records for internal review, audits, and inspections.
• Ensure quality documentation is processed in a timely manner to support production, release, and quality system requirements.
• Support the review and tracking of completed forms and records associated with manufacturing and quality activities.
• Assist with periodic housekeeping and organization of archived and active quality files.
• Support other quality-related administrative and operational tasks as assigned.

Required Education and Experience:

• High school diploma or equivalent required; an Associate degree or related education preferred. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment.
• Minimum of 1 year of experience in document control, records management, quality administration, or a related role in a regulated environment preferred.
• Experience working in a medical device, pharmaceutical, biotech, or other regulated industry preferred.
• Familiarity with quality documentation practices, document review, and record retention requirements preferred.

Skills and Abilities Required for This Job:

• Proficiency with standard MS Office software applications, including Word, Excel, and PowerPoint.
• Excellent computer and electronic equipment (e.g., printer/scanner) literacy, including the use of software for tracking, trending, and analysis.
• Displays attention to detail with strong documentation, spelling, grammar, and communication (verbal and written) skills.
• Proficient in planning, time management and organizational skills.
• Ability to complete work independently with minimal supervision.
• Ability to collaborate with cross-functional teams.

Physical Requirements:

• Requires prolonged periods of standing and sitting to support inspection, testing, and review activities.
• Must be able to work in a manufacturing, laboratory, and clean room environment, including compliance with applicable gowning and PPE requirements.
• Must be able to follow cleanroom, laboratory, and site safety protocols at all times.

Salary : $22