100,000's of Government Jobs

Search Government Jobs

Job Field: Legal Jobs
Location: San Diego, CA
Salary: $Not stated

JOB SUMMARY:

---

</tr>
<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 Quality Assurance Specialist is responsible for supporting the Quality Management System, including reviewing Production History Records PHR / Production Batch Records PBR, QA release of product to inventory, and documenting non-conformances and deviations as they pertain to materials and production processes.
Responsibilities
Perform final document and data review for raw materials via incoming inspection documentation, and for intermediate and finished bulk via PHR or PBR review
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
Assist with PHR/PBR archiving, including scanning and filing
Requirements
Associates Degree in Life Science or Engineering Bachelors 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
EEO/AA M/F/V/D

KEY REQUIREMENTS:

---

None Associate degree