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11223
Contract

QA Specialist/ Product Release

Location: San Diego, California

Connexion strives to be the unrivaled staffing solution for both job seekers and hiring organizations by expertly connecting talent with opportunity. We build world class teams for our customers, and better the lives of our candidates by providing them with fulfilling careers.

 

Connexion would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:

 

QA Specialist/ Product Release

  • Open to recent grad with science related education interested in QA (with Bachelor’s degree is fine with 0 – 2 related experience),
  • Also open with high school with 4-6 years related experience or Associates with 2-4-year related experience
  • This position will be doing both Product Release and QI but will focus more on Product Release.
  • Batch record reviews for final release
  • Working on the COVID- 19 test kits
  • Will be cross trained with the Quality Inspection department

Job Summary

Quality Specialist is responsible for supporting and working within the Product Assurance Release team. Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensure that deadlines are met on time and within budget. Limited interface with other departments and business or marketing partners. Work independently with limited supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Performs batch record review of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits.
  • Performs approval and final release of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits using the EDMS and ERP system.
  • Conducts compliance audits of less complex documentation & data.
  • Assists in internal and/or walk around audits.
  • Serves as QA interface with limited responsibilities.
  • Prepares data packages for external customers and regulation bodies.
  • Performs compliance activities such as QA Holds, room releases, at-risk processing, etc.
  • Assists in new employee training.
  • Performs initial troubleshooting activities.
  • Assists in maintenance & reporting of department metrics.
  • Review and assess the appropriateness of document changes in accordance with internal procedures with oversight and guidance.

Education

  • Typically requires High school and 4-6 years related experience or AA and 2-4-year related experience or BS and 0-2 years related experience

Experience

  • Basic knowledge of QSR & ISO requirements
  • Basic computer skills

Skills

  • Learning Skills
  • Communication skills

 

 

 

 

Date Posted: 3/19/2020

Hiring Organization: Connexion Systems & Engineering

Job Title: Quality Assurance/ Product Release

Industry: Medical/IT

Location: San Diego, CA 92101    

Employment Type: Full-Time, Contract

Pay Range: 19-22/hr.  depending on experience

Duration: 6months++

Job #: bh11223

 

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ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776