Coordinator I, Quality Records

Werfen•San Diego, CA

About The Position

The Quality Records Coordinator is responsible for the review and audit of Manufacturing and Quality Control (QC) related records associated with the release of products in manufacturing, primarily product Device History Records (DHRs). The Quality Records Coordinator oversees the review of DHRs in order to complete the final release of accepted sub-components and finished good products.

Requirements

High school diploma
Good communication, organizational, and time management skills; ability to pay close attention to detail.
Ability to work as part of a team.
Ability to identify and correct problems.

Nice To Haves

Bachelor’s degree (Life Sciences) a plus.
Minimum one year’s previous related Quality Records/Quality Assurance experience preferred; previous experi- ence within a regulated medical device manufacturing or pharmaceutical environment strongly preferred.
Knowledge of cGMP, GDP, FDA, and ISO preferred.
Working knowledge of Microsoft Office.
Experience with large enterprise resource planning (ERP) system and accounting software packages preferred.
Previous regulatory audit experience a plus.
Technical writing background/experience a plus
Must be self-motivated and could work with minimal supervision; must also be able to work as part of a team.

Responsibilities

Review DHRs for assigned products; as appropriate, approve product release through the Enterprise Resource Planning system (ERP).
Audit DHRs to ensure accuracy, legibility, and traceability
Continually work to achieve assigned review time goals; meet unscheduled in workload as necessary to ensure timely release of product.
Responsible to scan/archive completed DHRs
Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve ques- tions, inconsistencies, or missing data issues.
Remain current with all specifications and requirements on which quality records are based.
Remain up to date with current Good Manufacturing Processes (cGMP), as well as with manufacturing’s mate- rial/product process flow.
Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed.
Ensure priority to urgent matters.
Provide additional administrative support as directed.
Participate in regulatory audits as needed.
Ensure and maintain compliance with the company’s quality system requirements through training and adher- ence to policies, procedures, and processes.
Other duties as assigned.
Carries out duties in compliance with established business policies.
Interface with all functions and levels of management as needed.
Other duties as assigned, according to the changing needs of the business
DHR Review and Release
Deviation process (Affected DHRs)
Nonconformance process
Validation DHR Review