We are seeking a highly motivated and experienced Temporary Quality Systems Specialist to join our dynamic team in Morrisville, NC. This role is critical to ensuring the development and implementation of robust quality systems that align with regulatory standards and support our mission to deliver cutting-edge solutions in the life sciences industry. The ideal candidate is self-driven, highly organized, and thrives in a fast-paced, collaborative environment. Exceptional communication and writing skills are essential, as is the ability to work flexibly across cross-functional teams, including occasional non-standard hours to meet project demands.

Major Responsibilities

•Develop, implement, and maintain effective quality systems that comply with regulatory standards, including ISO 9001:2015, ISO 13485:2016, ISO 14971, ISO 15189, and Good Laboratory Practice (GLP).
•Write and review high-quality documentation, including standard operating procedures (SOPs), quality manuals, and compliance reports, ensuring clarity and adherence to regulatory requirements.
•Collaborate with cross-functional teams to integrate quality processes into research, development, and operational workflows.
•Conduct risk assessments, audits, and gap analyses to ensure continuous improvement of quality systems.
•Provide training and guidance to staff on quality system requirements, GLP principles, and regulatory compliance.
•Analyze data and metrics to identify trends, resolve issues, and drive decision-making to maintain quality standards.
•Stay current with evolving regulatory requirements and industry best practices, ensuring Codetta Bio remains at the forefront of compliance.

Required Knowledge:

•ISO 9001:2015
•Good Laboratory Practices (GLP)
•ISO 13485:2015
•ISO 14971
•ISO 15189

Required Qualifications:

•Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, biomedical engineering) or a related field.
•Minimum of 10 years of experience in a GLP-regulated environment, with a focus on quality systems development and implementation.
•Demonstrated expertise in developing and maintaining quality systems compliant with ISO standards and GLP regulations.
•Strong track record of writing and managing high-quality documentation for regulatory compliance.
•Experience conducting training, audits, and risk assessments in a life sciences or healthcare setting.
•Comfortable working in a high-energy, collaborative start-up environment with a commitment to accountability and excellence.

Please note: While we value the diverse experiences and backgrounds of all applicants, Codetta Bio is currently unable to support visa sponsorship.