Advanced Quality Assurance Specialist

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.

Pay Range:

Position Summary:

Are you passionate about science and have experience in quality assurance related activities? This could be the opportunity for you! To join a company that develops and provides a unique and cutting edge lineup of products and tools used by life science researchers, pharma, and diagnostic companies to make scientific discoveries, medical breakthroughs, understand the cause of diseases, develop new treatments, and much more!

As a Quality Assurance (QA) Specialist you will support the quality functions of Bio-Techne through quality systems development and improvement, document and records review, auditing, and other quality functions. The QA Specialist will understand and follow appropriate quality procedures to meet compliance standards, including ISO 9001, ISO 13485, and 21CFR820.

Key Responsibilities:

• Participate in cross-functional team meetings as a quality representative, assist in management of quality issues and offer input representing quality assurance (new product design, data reviews or root cause investigations).
• Work collaboratively with all functions to ensure understanding and conformance with quality requirements.
• Assist in Quality review of newly written or revised GMP specifications, documents, labels and literature for accuracy and completeness. Write documents as needed.
• Assist in Quality review of batch records for product manufacturing.
• Assist in monitoring quality systems through monthly complaint meetings, monthly reports, trending, and annual quality review.
• Assist in writing or reviewing newly written or revised validation plans and review the completed validations for accuracy and completeness.
• Assist in maintaining and/or developing companywide Quality systems including, but not limited to, quality audits, product validation, document control, acceptance activities, production and process control, and corrective and preventive action.
• Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance with the job.
• Follows applicable standard operating procedures (SOPs), including a good understanding of quality associated SOPs.
• Propose process improvements and areas for improvement to supervisor.
• Conduct inspections of raw materials, intermediates, and finished goods to ensure specifications and quality standards are met.
• Conduct inspection of product literature and labels to ensure accuracy.
• Performs additional duties as assigned.

Job Qualifications

Education and Experience:

• This position requires a minimum of a bachelor’s degree in a biological or chemical scientific discipline, with 1 - 3 years of related experience in quality activities in a science related field, or equivalent combination of education and experience.
• Must have the ability to work in a fast-paced environment with an attention to detail, organization, and time management skills. Should be able to work individually, but also as a contributing member of internal and cross-functional teams maintaining good communication skills, both verbally and in writing.
• Experience and understanding of ISO 9001 or ISO 13485 is preferred.

Knowledge, Skills, and Abilities:

• Attention to detail and organizational skills are required
• Working knowledge of Microsoft Word and Excel are required
• Computer entry, typing, or electronic document filing skills are require
• Must be able to work in a fast-paced environment where multitasking is required
• Must have excellent verbal and written communication skills
• Knowledge of technical, regulatory, quality and production management systems
• Knowledge of documentation principles and processes
• Skills in accuracy, clarity, and proofreading
• Skills in problem solving, root cause analysis, and appropriately evaluate a course of actions