Job Description

HEROES WORK HERE! DO YOU WANT TO JOIN A COMPANY WHERE YOU CAN BE A HERO TOO?

We deliver innovative, diagnostic solutions that improve the lives of patients and their families and are proud to be one of the heroic diagnostic companies that is in this fight against COVID-19.

As a member of GenMark’s team, you’ll get to be part of an organization where we embody our cultural beliefs in everything we do. The following is a glimpse of what our culture looks like and If you'd like to join us, we encourage you to apply as our company is growing!

• GO BIG - We never settle and challenge what’s possible
• WIN TOGETHER - We are one team with a shared purpose
• OWN IT - We step up, drive it, and deliver it
• BE BOLD - We empower ourselves and others

WHAT YOU WILL DO AT GENMARK 

The Document Control Specialist, Product Release position is responsible for the review and release of product which has been manufactured at GenMark. The manufacturing batch records are reviewed to assure compliance with the device master record, assures nonconforming material reports that affected the manufactured product are closed, assures any deviations were executed as defined, and assures good documentation practices (GDP) were followed. The Document Control Specialist is responsible for handling tasks associated with Document Control, including processing, archival, filing, scanning, indexing and formatting new and existing documents within guidance of the document control QMS procedures and the MasterControl documentation software.

This position actively manages the document record retention process through the contracted documentation archival supplier. Assures records archived are well documented and logged to support potential future retrieval records as needed. Represent Quality Assurance and interacts with cross-functional departments to provide quality guidance. Ensure compliance with all relevant quality management system and regulatory requirements (e.g., ISO 13485, 21 CFR 820). Assist as a backup to the change control processes to ensure standardization, accuracy, and completeness of documents prior to release. Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.

_                    THIS IS A 1ST SHIFT POSITION + WEEKEND OVERTIME AS NEEDED_

ESSENTIAL DUTIES & RESPONSIBILITIES

• Responsible for ensuring that manufactured product meets its device master record requirements and is ready for product release.
• Train and provide oversight to product release staff in the review and release of manufacturing batch records
• Responsible for working with quality inspection and manufacturing personnel to facilitate efficient review and release of products.
• Creates a nonconforming material report (NCR) if deficiencies are found, QA approves NCR initiation, and provides input to NCR investigations, as necessary.
• Assist as a backup to the change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
• Working with Document Control in archiving and retrieval of retained paper records
• Support quality system audits by providing requested manufacturing batch records.
• Other duties may be assigned

EDUCATION AND EXPERIENCE 

• Experience working in an FDA regulated environment and in the IVD industry is preferable.
• 1-2 years of experience is preferable.
• Experience with Master Control a plus.
• Experience with ERP system a plus.
• Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents.
• Experience with Document and Change Control electronic systems (preferably Master Control)
• Experience working with cross-functional areas (e.g., Manufacturing, Operations)
• Must be a hands-on, self-directed, detail oriented and conscientious individual
• Complete work in a timely, accurate and thorough manner
• Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.

ABOUT GENMARK

GenMark’s ePlex true sample-to-answer system symbolizes the evolution of eSensor technology combined with digital microfluidics. ePlex offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report, and is the only true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency.

GenMark is headquartered in Carlsbad, California and maintains its European Operation in Zug, Switzerland.