Manufacturing Quality Specialist

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.

Position: Manufacturing Quality Specialist

Location: South San Francisco, CA - 94080

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Monday to Friday - Flexible to start the shift between 07:00 AM to 09:00 AM (8 Hours Minimum)

Summary

The Quality Assurance professional will provide quality oversight for processes and projects, conduct compliance assessments and internal audits, support compliance with current regulations and ISO 9001 requirements, and contribute to continuous improvement initiatives. The role will also support the development and use of AI within Quality and provide Quality Assurance support for consumable, hardware, and software products supporting Genetic Science and Next Generation Sequencing applications.

Key Responsibilities:

• Provide Quality oversight for processes and projects and perform compliance assessments.
• Support the development and use of AI within Quality.
• Conduct facility, personnel, and documentation quality assessments to identify errors and ensure compliance with site procedures and ISO 9001.
• Provide Quality Assurance support for the development and post-market support of consumable, hardware, and software products supporting Genetic Science and Next Generation Sequencing applications.
• Lead product transfers and evaluate non-conformances.
• Investigate customer complaints and develop CAPAs.
• Improve quality processes and systems and drive sustaining activities.
• Participate in rapid response processes and support deviation events.
• Ensure critical deviation-related issues are reported to the appropriate areas and Quality Management.
• Review and approve procedures, training documents, and forms of moderate to high complexity.
• Conduct quality reviews and approvals of deviations, process changes, and engineering change controls.
• Serve as the Quality Assurance representative during Root Cause Analysis investigations.
• Conduct daily reviews of key quality performance metrics.
• Perform internal quality audits and support resolution of identified non-conformities.
• Identify continuous improvement opportunities.
• Participate in Practical Process Improvement (PPI) initiatives.

Required Skills

• Bachelor's degree required; Science-related field preferred.
• A minimum of 2+ years of Quality Assurance experience in a biotech or pharma environment.
• Should have experience in performing internal audits
• Strong hands-on experience with risk assessments, Root Cause Analysis, CAPA planning and development experience.
• Quality background with experience supporting regulated processes.
• Experience with ISO requirements and internal audits.
• Gap assessments against ISO standards.
• Strong problem-solving skills.
• Strong written and verbal communication skills.
• Ability to assess compliance and identify quality issues.
• Ability to support investigations, non-conformance resolution, and continuous improvement initiatives.

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