Our Passion. Your Results.
Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.
As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality
in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.
The Quality Records Coordinator is responsible for the review and audit of Manufacturing and Quality Control (QC) related records associated with the release of finished goods, primarily product Device History Records (DHRs). The Quality Records Coordinator oversees the archives of DHRs, Device Master Records (DMRs) and other quality records, and is responsible for maintaining accuracy, legibility, traceability, and retrieval of such records. Additionally, the Quality Records Coordinator is responsible for ensuring quality records associated with the release of product for packaging and/or distribution are complete and accurate.
Review DHRs for assigned products; as appropriate, approve product release through the Enterprise Resource Planning system (ERP).
Continually work to achieve assigned review time goals; meet unscheduled in workload as necessary to ensure timely release of product.
Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve questions, 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 manufacturings material/product process flow.
Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed. ? Identify areas in need of improvement, particularly with regards to accuracy, completeness, and cycle times of the quality record process.
Ensure priority to urgent matters. Identify issues and work to implement corrective action. Provide additional administrative support as directed.
As needed, participate in regulatory audits.
Work on assigned special projects as directed.
Provide additional administrative support as directed.
Ensure and maintain compliance with the companys quality system requirements through training and adherence to policies, procedures and processes.
Other duties as assigned.
High school diploma or equivalent experience preferred; Bachelors degree (Life Sciences) a plus.
Three (3) to five (5) years previous related Quality Records/Quality Assurance experience; previous experience within a regulated medical device manufacturing or pharmaceutical environment 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 have the ability to work with minimal supervision; must also be able to work as part of a team.
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.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
Werfen is a global leader in in vitro diagnostics (IVD) in the specialties of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.
We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.