Clerk, Quality Records (Temp to Hire)

Job Title: Clerk, Quality Records

 

Role Level: Individual Contributor

 

Supervisor/Manager Title: Supervisor, Quality Control.

 

Job Location & Environment: Irvine, CA – Corporate Office / Controlled Cleanroom Environment

 

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.
• Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs.

Required Education and Experience:

• High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment designed to evaluate comprehension, language, and related abilities at a high school level.
• 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.
• Ability to read, comprehend and speak English, and good communication skills required.
• Basic computer skills.

 

Physical Requirements:

• Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed.
• Must be able to stand, walk, and sit for prolonged periods of time.
• Must be able to push, pull, twist, climb, balance, stoop, kneel, and crawl.
• Must be able to perform repetitive motions such as reaching and grasping.
• Ability to lift or move materials up to 25 pounds.