Blooper
Position Overview
Blooper Biotech, Inc. is seeking a diligent and detail-oriented Quality Assurance (QA) Specialist to join our Regulatory and Quality team. The QA Specialist will ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ISO standards across laboratory and clinical operations. This role plays a critical part in maintaining the integrity, safety, and regulatory compliance of our research and development processes.
Key Responsibilities • Conduct regular audits of laboratory and clinical operations to ensure compliance with GMP, GLP, and ISO standards. • Develop, implement, and maintain quality systems, including SOPs and quality manuals. • Assist in the preparation of regulatory submissions by providing QA documentation and data validation. • Investigate and document deviations, non-conformances, and corrective/preventive actions (CAPAs). • Provide training and guidance to staff on quality standards, procedures, and best practices. • Maintain accurate and organized QA records and reports for internal and external audits. • Collaborate with cross-functional teams to ensure quality standards are integrated into research and operations.
Qualifications • Bachelor's degree in Life Sciences, Quality Management, or related field. • 2+ years of experience in a quality assurance role within biotech, pharma, or clinical research. • Strong knowledge of GMP, GLP, ISO 9001/13485, and regulatory guidelines (FDA, EMA). • Experience with audits, CAPA processes, and quality systems management. • Excellent organizational and documentation skills with attention to detail. • Strong communication and training abilities. • Ability to work collaboratively across scientific, regulatory, and operational teams.
About Blooper Biotech
At Blooper Biotech, we believe science should have purpose. Our mission is to accelerate discovery and deliver breakthrough therapies that improve patient lives worldwide. Join our Regulatory and Quality team and play an essential role in ensuring our research meets the highest global standards.
Blooper Biotech, Inc. is seeking a diligent and detail-oriented Quality Assurance (QA) Specialist to join our Regulatory and Quality team. The QA Specialist will ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ISO standards across laboratory and clinical operations. This role plays a critical part in maintaining the integrity, safety, and regulatory compliance of our research and development processes.
Key Responsibilities • Conduct regular audits of laboratory and clinical operations to ensure compliance with GMP, GLP, and ISO standards. • Develop, implement, and maintain quality systems, including SOPs and quality manuals. • Assist in the preparation of regulatory submissions by providing QA documentation and data validation. • Investigate and document deviations, non-conformances, and corrective/preventive actions (CAPAs). • Provide training and guidance to staff on quality standards, procedures, and best practices. • Maintain accurate and organized QA records and reports for internal and external audits. • Collaborate with cross-functional teams to ensure quality standards are integrated into research and operations.
Qualifications • Bachelor's degree in Life Sciences, Quality Management, or related field. • 2+ years of experience in a quality assurance role within biotech, pharma, or clinical research. • Strong knowledge of GMP, GLP, ISO 9001/13485, and regulatory guidelines (FDA, EMA). • Experience with audits, CAPA processes, and quality systems management. • Excellent organizational and documentation skills with attention to detail. • Strong communication and training abilities. • Ability to work collaboratively across scientific, regulatory, and operational teams.
About Blooper Biotech
At Blooper Biotech, we believe science should have purpose. Our mission is to accelerate discovery and deliver breakthrough therapies that improve patient lives worldwide. Join our Regulatory and Quality team and play an essential role in ensuring our research meets the highest global standards.