Technical and Craft Labor - Quality Assurance Specialist

Job Description

Job Description

M-F 8-5 flexible with start time of 7-9 am with 8 hours work afterwards

Provide Quality oversight for processes and projects, perform compliance assessments, develop the use of AI within Quality, perform internal audits, and ensure compliance to current regulations.

A day in the Life:

Conduct facility, personnel, documentation quality assessments to find errors, ensure compliance with site procedures, ISO 9001.

Provide Quality Assurance support for the development and post-market support activities for consumable, hardware, and software products that support Genetic Science and Next Generation Sequencing applications.

Lead product transfer, evaluate non-conformances, investigate customer complaints, develop CAPAs, improve processes & systems, and drive sustaining activities.

Participate in rapid response processes and provide support for deviation events.

Ensure reporting of critical issues related to deviation events to the appropriate area and quality management.

Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity.

Conduct quality reviews and approvals of deviations and process and engineering change controls.

Serve as the quality assurance representative in Root Cause Analysis to support investigations.

Conduct daily reviews of key performance quality metrics.

Perform quality internal audits and resolve identified non-conformities.

Aid in identifying continuous improvement opportunities.

Participate in practical process improvement (PPI) initiatives.

Keys to Success:

Education

Bachelors Degree required, Science field preferred.

Experience

2 years Quality Assurance experience in biotech, Quality background

Great Written & Verbal Communication Skills

Problem-solving & Root cause analysis

Understanding of ISO requirements- internal audit experience

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.