Job Information
Bio-Techne Senior Quality Assurance Specialist in Minneapolis, Minnesota
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:
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 Senior 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 Senior 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.
Quality review of newly written or revised GMP specifications, documents, labels and literature for accuracy and completeness. Write documents as needed.
Quality review of batch records for product manufacturing.
Monitoring quality systems through monthly complaint meetings, monthly reports, trending, and annual quality review.
Perform internal department quality audits or audit other sister companies.
Writing or reviewing newly written or revised validation plans and review the completed validations for accuracy and completeness.
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.
Qualifications
Education and Experience:
This position requires a minimum of a bachelor’s degree in a biological or chemical scientific discipline, with 5 or more 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 and ISO 13485 is required. Experience with MDSAP regulation 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
Why Join Bio-Techne:
We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
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.