Highlights
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. 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.
Numbers & Facts
| Location | South San Francisco, CA |
| Industry | Computer/IT Services |
| Salary | $25–$30 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
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.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Similar Jobs
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