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Clinical Trials - Quality Assurance Analyst

Meet, Rochester, Minnesota, us, 55905


My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.Key Responsibilities:Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and SafetyProvide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.Strong purposeful presence on the manufacturing floorParticipates in and provides quality oversight for quality records including Deviations and Change Controls, assuring adherence to procedural requirements and regulatory expectations.Reviews and approves controlled documents, including Standard Operating Procedures, Protocols and Reports.Ensures that operations align with applicable regulationsGood Manufacturing Practices, Good Documentation Practices, Safety, and Controls.Contribute to and drive continuous improvement projects in cross-functional collaboration.Experience::Bachelors Degree in Biochemistry, Biology, Chemistry, or related science fieldDemonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practicesExperience managing projects through to completion meeting timelines.Ability to evaluate documentation and operations according to company procedures.Experience working with Quality SystemsStrong organizational skills and ability to manage multiple tasks at one timeEffective communication skills (both written and verbal)Demonstrated ability to work as both a team player and independentlyDisplay leadership attributes and drive improvement initiativesSolid understanding and application of aseptic behaviors and principlesWhy Join my client?Be part of a pioneering biotech company dedicated to developing cutting-edge therapies.Work in a collaborative and fast-paced environment with the opportunity to make a significant impact on the company’s success.Competitive compensation package, including benefits and opportunities for professional growth.