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Quality Control Specialist

Sequenom Inc.

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Location: San Diego, CA Posted Date: 4/30/2013 Position Type: Full time Job Code: 1154 Salary: Salary, Stock Options, Bonus Required Education: Associates Degree Areas of Expertise Desired: Manufacturing/Production
Quality Assurance
Quality Control

Description

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 Quality Control Specialist is responsible for supporting the Quality Management System, including review of manufacturing labels, incoming inspection and release of raw materials/components to inventory, and documentation of non-conformances as they pertain to materials and production processes.

Responsibilities:
•   Perform incoming inspection, data review, and release of raw materials/components
•   Coordinate the Material Review Board (MRB) meetings and assist in processing Non-Conforming Material Reports (NCMR) and Return Material Authorization (RMA), including generating reports and scheduling MRB meetings. Coordinate/implement process flow of non-conforming materials from submission to MRB, investigation, to final disposition
•   Oversee quarantine and status labeling of materials by coordinating with Materials Management
•   Participate in training programs to facilitate the proper use and implementation of quality systems
•   Manage documentation and follow-up for manufacturing reworks, manufacturing and freezer logbook issuance and review.   Notify and assist in resolving Production and Quality Control document deficiencies
•   Archive RMS and PHR/PBR , which includes occasional scanning of documents as requested by customers

Requirements

•   Associate’s Degree in Life Science or Engineering; Bachelor’s Degree preferred
•   2-5 years’ experience in a regulated medical device, in vitro diagnostic device, or pharmaceutical industry required
•   Experience inspecting from first article to final inspection required
•   Certified Quality Technician CQT preferred
•   Knowledge of inspection, test and measurement techniques, including statistical sampling plans, standard measurement tools such as digital multimeter, micrometer and caliper
•   Ability to create and maintain trend charts supporting, monitoring, and measuring activities
•   Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred
•   Strong computer skills with MS office applications including Outlook, Excel, and PowerPoint
•   SAP or similar Enterprise Resource Planning (ERP) system knowledge required
•   Ability to lift up to 25 pounds

To apply, please visit http://www.sequenom.com/Careers/Jobs  

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