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.
Position Summary:
As an Advanced 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 Advanced QA Specialist will understand and follow appropriate quality procedures to meet compliance standards, including ISO 9001, ISO 13485, 21CFR11, and 21CFR820.
This position will be responsible for supporting the Immunoassay Business Unit focusing on the Luminex product line.
Key Responsibilities:
- Participate in cross-functional team meetings as a quality representative for Luminex and immunoassays, 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. Contribute to educational initiatives focused on quality assurance and company QMS processes.
- Assist in Quality review of newly written or revised RUO and IVD specifications, documents, labels and literature for accuracy and completeness. Write documents as needed. Review of batch records for product manufacturing.
- 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, 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.
- Performs additional duties as assigned.
Education and Experience:
- This position requires a bachelor’s degree in a biological or chemical scientific discipline, with 3 - 5 years of related experience in quality activities, preferably focusing on immunoassay development, or equivalent combination of education and experience.
- Or, a Master's degree with up to 2 years of relevant experience.
- Must have the ability to work in a fast-paced environment with an attention to detail, organization, and time management skills are required.
- 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.
Knowledge, Skills and Abilities:
- Experience in Luminex or similar multiplex immunoassay development is preferred
- Knowledge of applicable guidelines and regulations, namely ISO 9001, ISO 13485, 21CFR11, and 21CFR820
- Attention to detail and organizational skills are required
- Working knowledge of Microsoft Word and Excel are required, Microsoft AX is preferred
- 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 good 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.
Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.
Bio-Techne is an E-Verify Employer in the United States.