Quality Specialist

San Carlos, CA 94070

Posted: 06/24/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 15951

Bayside Solutions is seeking a Quality Specialist  to be part of our Client’ s team in the Peninsula. This is an opportunity to work with a molecular diagnostics company that engages in the detection and monitoring of life threatening viral diseases in the areas of cervical cancer, HIV/AIDS, hepatitis, breast and ovarian cancer, and organ transplant rejection.

Our Company Bio:  Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Summary of Responsibilities may include but are not limited to
  • Coordinate Document Control and Quality Training activities
  • Manage new Supplier Qualification activities and ensure compliance Supplier qualification and Supplier Corrective Action (SCARs) with ISO 13485 standards and 21 CFR 820
  • Monitor the progress of CAPAs, NCRs and SCARs investigation and write, investigate and generate reports as needed
  • Work with internal teams as well as suppliers and customers for the investigation of NCRs and SCARs and the implementation of corrections, corrective and preventive actions
  • Perform Routine equipment monitoring; support equipment maintenance, calibration and validation activities
  • Ensure segregation, correct status labeling and locations of inventory
  • Write, revise and review Standard Operating Procedures, Technical Procedures, Quality Control and Manufacturing documents
  • Assist in batch records review and product release
  • Participate in the implementation of UDI (Unique Device Identifier) for existing products and products in development

Qualifications
  • BS/BA in biology, chemistry or related filed
  • 2-3 years’ experience with In Vitro Diagnostic / Medical Device manufacturing
  • Good understanding of IVDR, FDA 21 CFR 820, ISO 13485
  • Excellent written and verbal communication skills. Able to read, write, and communicate fluently in English
  • Comfortable in a quick paced environment, highly detailed yet flexible, able to shift priorities when needed
  • Experience in the lab and with flow cytometry experience is a plus

Work conditions and physical requirements
  • The work is performed indoors, in a general office environment and in a biology laboratory
  • Ability to work for extended periods of time on a computer
  • Some tasks require exposure to hazardous and/or toxic chemicals and potentially hazardous biological materials
  • Ability to climb on mobile platform ladder and lift up to 40lbs
  • Requires periodic on-call responsibilities outside of business hours to ensure 24/7 temperature monitoring for products

Rochelle Chang-Ledwith

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