SR. DOCUMENTATION CONTROL SPECIALIST
Job Field: Legal Jobs
Location: San Diego, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Join the biotech company that is dedicated to improving healthcare through revolutionary genetic analysis solutions. Sequenom is on the forefront of cutting-edge technologies and ground-breaking clinical diagnostic tests. Headquartered in San Diego, with offices located around the world, we provide the opportunity to collaborate with talented and dedicated scientific leaders while developing and expanding your own career. We know our strength and competitive advantage comes from our people so we strive to maintain a motivated team and an environment that supports diversity, encourages creativity, and most importantly, fosters innovation. Our employees are rewarded with excellent compensation and top-notch benefits. Consider joining the Sequenom team, where you can help make an impact in revolutionizing medical technology.
The Sr. Documentation Control Specialist will be responsible for managing the Sequenom Center for Molecular Medicine SCMM documentation management, learning management, and record retention systems. The ideal candidate will maintain and oversee the document change control process including change orders affecting new product or process development the training system and storage of SCMM laboratory records. Additional responsibilities include implementing and configuring the electronic document management and electronic learning management system requirements, and supporting SCMM management during external audits from third parties e.g. CAP, CLIA, State Accreditation Inspections.
Responsibilities
Responsible for managing SCMM electronic Document Management System, electronic Learning Management system MasterControl.
Coordinate the interface with the business Enterprise Resource Management software SAP for new part BOM and router creation
Develop and implement document control systems plans, polices, procedures and work instruction
Manage and maintain all quality records and the document storage vault
Manage revisions to document management system documentation, including Laboratory Operating Procedures and raw material/product specifications
Provide support for development of training initiatives related to MasterControl and change control processes
Requirements
Bachelors degree or equivalent combination of education and work related experience required.
8+ years of documentation control experience. Medical device, biotechnology or diagnostic devices industry highly desired
Prior direct experience with implementing, maintaining and improving a document control system
Strong knowledge and skills with using MS office and Adobe applications including Outlook, Excel, and PowerPoint
Experience with MasterControl and SAP strongly preferred
Ability to handle multiple projects simultaneously
To apply, please visit http//www.sequenom.com/Careers/Jobs
EEO/AA M/F/V/D
KEY REQUIREMENTS:
None Bachelors degree