Quality Assurance Specialist

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role Mirus Bio is expanding and has an immediate opening for a Quality Assurance Specialist to perform document control and quality assurance review of the Mirus Bio product portfolio to maintain a high level of quality and performance. The responsibilities outlined below may fluctuate depending on the number of projects and current business priorities. We are currently on the lookout for a hands-on individual to join our passionate team. If you are someone who thrives in a collaborative, innovative, and fast-paced environment, join us in shaping the future of our industry and be a part of a team that continues to redefine possibilities. This role works cross-functionally with all departments within Mirus Bio. Assist with revision of all version-controlled documents in the quality system Perform quality review of labels and data generated by all departments for completeness, accuracy and compliance Review and release raw materials, intermediate products and finished products Create and approve of product specific quality documentation such as Certificates of Analysis, Certificates of Origin and product questionnaires Assist with supplier quality including qualifying new suppliers and requalifying current suppliers Maintain training records for all employees Assist with revisions to quality procedures and process improvements Assist with onsite audits by customers or regulatory agencies Manage deviations, investigations, change controls and CAPAs to ensure timely closure Assist with review of customer complaints and inquiries as required Serve as a subject matter expert on Qualio electronic quality management system Perform quality related activities in Mirus inventory system and temperature monitoring systems Serve as a back-up for various quality responsibilities as needed Follow GMP guidelines and ensure quality compliance Interface and work amicably with other departments including facilities, shipping, production and R&D within Mirus Share information with fellow employees Build positive relationships during internal and external interactions Represent the company in a positive and professional manner Demonstrate behavior outlined within the Mirus Bio Employee Handbook Perform other duties as assigned by Sr. Quality Manager Who You Are Minimum Qualifications: Bachelor’s degree in Biology, Chemistry, or other Life Science discipline 2+ years of experience working in a cGMP environment Preferred Qualifications: At least 5 years’ experience preferred Experience with quality document review Work productively in a team environment Work in an organized manner, to make critical observations, and to maintain good records of the results Excellent verbal and written communication skills Proficiency with Microsoft Office including Excel, Word and PowerPoint Experience with maintaining and/or qualifying suppliers Experience or qualification to perform quality auditing Previous experience working for a life sciences company is preferred Experience with cell biology techniques such as, mammalian tissue culture and transfection

Salary : $56,000 - $79,000