Supervisor, Qa Jobs

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Position Summary:

Write and review qualification and validation documentation, such as protocols, reports, and SOPs for new facilities, cleanroom validations, and commissioning activities; ensure validations are executed in accordance with procedures and protocols; support non-conformance activities, MRB events, CAPA program and Change Control; collaborate on validation projects with various departments and support in achieving the validation requirements; support with the environmental monitoring program as required; participate in and support ISO audits, MSDAP audits and customer onsite audits; train and provide quality-related guidance to department members or others in the organization as needed; and lead a team of QA-Validation Engineers to perform the above activities. Write or review newly written or revised product, equipment or laboratory validation plans and review the completed validations for accuracy and completeness; train and provide quality-related guidance to department members or others in the organization as needed; dene and propose appropriate processes that are in line with the Quality Mgmt. System and internal Quality System Requirements; make recommendations and lead group projects, priorities and quality strategies related to product, equipment or laboratory validations; analyze data, draw conclusions and make decisions for next steps on assigned projects; maintain and/or develop Quality systems including, but not limited to, quality audits, product validation, document control, acceptance activities, production and process control, and corrective and preventive action; review newly written or revised product specications, documents, labels and literature for accuracy and completeness; write documents as needed; report required metrics to management on a periodic basis; monitor quality systems through periodic complaint meetings, reports, trending, and annual quality review; prepare for and attend meetings where Quality Assurance presence is required related to product, equipment or laboratory validations; use knowledge and prior experience to troubleshoot dicult problems arising in daily work; follow company policies and practices as outlined in the Handbook and follow guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance with the job. Oer input representing QA (new product design and data reviews, document meetings, kit pack, etc.), collaborate on projects with a broad scope, high impact or complexity, may lead projects of moderate complexity; utilize knowledge of quality/regulatory standards including ISO 9001, ISO 13485; ISO 14001.

Requirements:

Bachelor’s degree in Biology, Pharmaceutical Sciences, or equivalent, or closely related scientific discipline, with five (5) years of experience as a quality assurance engineer, validation engineer, or related engineering occupation in quality assurance and validation; OR Master’s degree in Biology, Pharmaceutical Sciences, or equivalent, or closely related scientific discipline and two (2) years of experience as a quality assurance engineer, validation engineer, or related engineering occupation in quality assurance and validation. Must possess at least 2 years of experience with each of the following: quality management systems; ISO 9001, ISO 13485, ISO 14001, or related quality regulations for medical device and/or pharmaceutical manufacturing; and validation process and design

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Bio-Techne is an E-Verify Employer in the United States.