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Quality Assurance Specialist

TekWissen Group
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Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands. 

Position:         Quality Assurance Specialist
Location:        South San Francisco,CA 94080
Duration:        12 Months
Job Type:        Temporary Assignment    
Work Type:     Onsite
Shift:               Monday To Friday From 08:00 AM To 05:00 PM(flexible with start time of 07:00 AM - 09:00 AM with 8 hours work afterwards).

Summary:

  • Quality Assurance professional responsible for quality oversight, compliance assessments, internal audits, and continuous improvement.
  • Supports compliance with regulations, site procedures, and ISO 9001 requirements.
  • Provides QA support for product development, product transfer, and post-market activities involving consumable, hardware, and software products.
  • Supports Genetic Science and Next Generation Sequencing (NGS) applications.
  • Supports non-conformance investigations, customer complaints, CAPAs, deviations, and root cause analysis.
  • Supports the use of AI within Quality processes.
  • Works cross-functionally to identify quality risks, improve processes, and maintain regulatory compliance.

Responsibilities:

  • Conduct facility, personnel, and documentation quality assessments.
  • Identify errors, quality risks, and compliance gaps.
  • Ensure compliance with site procedures and ISO 9001 requirements.
  • Provide QA support for product development and post-market activities.
  • Support consumable, hardware, and software products used in Genetic Science and NGS applications.
  • Lead product transfer activities.
  • Evaluate and investigate non-conformances and customer complaints.
  • Develop and implement CAPAs.
  • Support rapid response processes and deviation events.
  • Escalate critical deviation-related issues to appropriate teams and Quality Management.
  • Review and approve procedures, training documents, and forms.
  • Conduct quality reviews and approvals of deviations, process changes, and engineering change controls.
  • Serve as the QA representative during Root Cause Analysis and investigations.
  • Review key quality performance metrics and identify trends.
  • Conduct internal quality audits and resolve audit findings and non-conformities.
  • Identify continuous improvement opportunities.
  • Participate in Practical Process Improvement (PPI) initiatives.
  • Support implementation and use of AI within Quality processes.

Required Skills:

  • Bachelor's degree required; Science-related field preferred.
  • 2+ years of Quality Assurance experience.
  • Biotechnology or related quality environment experience.
  • Knowledge of ISO 9001 requirements.
  • Internal audit experience.
  • Understanding of quality systems and regulatory compliance requirements.
  • Experience with deviations, non-conformances, CAPAs, and change controls.
  • Root Cause Analysis and investigation experience.
  • Experience conducting quality assessments and compliance reviews.
  • Ability to identify, investigate, and resolve audit non-conformities.
  • Strong problem-solving and analytical skills.
  • Ability to determine appropriate corrective and preventive actions.
  • Ability to analyze quality metrics and identify trends and improvement opportunities.
  • Ability to support quality process and system improvements.
  • Familiarity with AI applications in Quality is preferred.
  • Excellent written and verbal communication skills.
  • Strong attention to detail.
  • Ability to communicate critical quality issues clearly and effectively.
  • Ability to work cross-functionally with Quality, Engineering, Manufacturing, and other teams.
  • Strong organizational and analytical skills.
  • Ability to support investigations and drive issues toward resolution.
  • Continuous improvement mindset.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.