Document Control Specialist I, Product Support
Company: GenMark Diagnostics, Inc.
Posted on: February 24, 2021
Document Control Specialist I, Product Support 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
- 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
- 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
- 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
- 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.,
- Must be a hands-on, self-directed, detail oriented and
- 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
Keywords: GenMark Diagnostics, Inc., San Diego , Document Control Specialist I, Product Support, Other , Carlsbad, California
Didn't find what you're looking for? Search again!