Quality Assurance Specialist
13 hours ago
Quality Assurance Specialist
About the Role:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Commonwealth Sciences, Inc. in Rochester, MN. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our laboratory data and processes.
Key Responsibilities:
- Develop and implement QA strategies to ensure compliance with GxP regulations and company standards.
- Perform audits on raw data and final reports to ensure accuracy and compliance.
- Monitor laboratory quality assurance activities to determine conformance with policies and procedures.
- Review documentation for adherence to quality standards.
- Ensure facilities, equipment, and processes comply with regulations and company standards.
- Provide QA support for change controls, deviations, investigations, and CAPA's.
- Develop and maintain compliance-related metrics and reports.
- Make recommendations for correction and improvement as necessary.
- Provide oversight of personnel training record management.
- Support internal and external audits as assigned.
- Review and update Quality Assurance procedures.
- Maintain audit forms and QA records.
Requirements:
- Bachelor's degree in quality assurance or science-related field.
- Minimum of 5 years in GxP or equivalent regulatory environment.
- Excellent knowledge of GLP and GCP requirements.
- Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
- Experience with reviewing laboratory data and computer-validated data collection systems.
- Able to understand published methodology to audit existing test methods.
- Thorough understanding of governing regulations and scientific literature.
- Experience performing quality process audits and reviewing deviations and CAPA.
- Solid working knowledge of Microsoft Office software.
- Possess excellent time and project management skills.
- Possess excellent interpersonal and communication skills.
- Background in molecular biology, virology, and/or serology is a plus.
- CRO experience is a plus.
- Experience with eQMS (Qualio) is a plus.
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