Hobson Prior are working with a growing biotech company based in Rochester, Minnesota who are looking for a QA Specialist to join them on a permanent basis. Our client's mission is to provide ground-breaking solutions to support virus, gene and cell therapies in order to improve the quality of life for patients worldwide.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Leading the GLP/GCP QA Strategy implementation, delegated GLP/GCP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.
• To complete data audits and report reviews to assure accuracy and compliance with GLP/GCP and CLIA regulations, study protocols and laboratory Standard Operating Procedures.
• An in-depth understanding of scientific studies in order to evaluate new test methods and schedule laboratory inspections.
• Assists in maintaining efficient Quality Assurance operations by advising and assisting in the installation of QA programs.
• Audits GLP/GCP and CLIA final reports to ensure that they are accurate and supported by raw data.
• Able to understand published methodology to audit existing test methods and ensure accuracy.
• Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.
• Knowledge of the general principles of standard molecular biology, virology and serology.
• Ability to make complex mathematical computations, use statistical techniques in the treatment of data, and interpret and apply findings.
• Monitors quality assurance activities of the laboratory to determine conformance with authorized policies and procedures and with sound practice.
• Any other assigned duties.

Key Skills:

• Must be detail oriented, capability to meet deadlines. PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required).
• Have excellent time and project management skills and effective communication, consulting, customer service and problem-solving skills.
• Must be able to clearly speak, write and read, including the ability to understand and verify scientific text and data.

Requirements:

• Requires bachelor's degree in a relevant field, Master's preferred or equivalent experience.
• A minimum of 5 years in GLP/GCP or equivalent regulatory experience.
• Working knowledge of GLP/GCP and CLIA regulations and the ability to interpret and apply these to daily work.
• Working knowledge of laboratory procedures and computer validated data collection systems in a preclinical and clinical environment.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.