QA Specialist
Job Details
Entry
Minneapolis - Minneapolis, MN
Full Time
Bachelor's Degree
None
Day
Quality & Regulatory
Description

By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

POSITION SUMMARY

The responsibilities of this position are to support the Quality Assurance function within Bio-Techne through quality systems development, quality systems auditing, documentation review, and other QA functions.

Perform additional duties as assigned.

ESSENTIAL FUNCTIONS

  1. Assist in Quality review of newly written or revised GMP specifications, documents, labels and literature for accuracy and completeness. Write documents as needed.
  2. Assist in Quality review of batch records for product manufacturing.
  3. Assist in monitoring quality systems through monthly complaint meetings, monthly reports, trending and annual quality review.
  4. Assist in writing or reviewing newly written or revised validation plans and review the completed validations for accuracy and completeness.
  5. 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.
  6. 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 to the job.
  7. Performs additional duties as assigned.
Qualifications

Education and Experience:

This position requires a bachelor’s degree in a scientific discipline, with a minimum of 0 to 2 years of related experience in QA activities in a science related field, or equivalent combination of education and experience.  Attention to detail, organization, and data analysis skills are required.  Working knowledge of Microsoft Word and Excel are required.  Computer entry and/or typing skills are desirable.  Must be able to work in a fast pace environment, multi-task, and have good communication skills, both verbally and in writing.

JOB SPECIFICATIONS (continued)

Knowledge, Skills, and Abilities:

  1. Knowledge of functions and ability to perform necessary tasks.
  2. Knowledge of safety and company procedures and practices.
  3. Knowledge of quality systems.
  4. Knowledge of regulatory and ISO requirements.
  5. Knowledge of protein and antibody production requirements, QC testing and related acceptance activities.
  6. Knowledge of documentation principles and processes. 
  7. Skills in project management and completion.
  8. Skills in accuracy, clarity and proofreading.
  9. Skills in problem solving; including the ability to identify root cause and appropriately evaluate a course of action. 
  10. Ability to write clearly and effectively transfer thoughts, ideas and instructions to written work.
  11. Ability to cooperate with departments to effectively communicate goals and action items.
  12. Ability to represent the quality system effectively.
  13. Ability to convey necessary QA information to participants at the meetings and to bring relevant information back to QA.
  14. Ability to apply applicable quality requirements.
  15. Ability to be flexible.
  16. Ability to act independently on routine assignments or projects.
  17. Ability to plan, organize and multi-task to complete assignments in an efficient manner.
  18. Ability to communicate professionally, both oral and written.
  19. Ability to pay attention to details and perform at a high-level accuracy.
  20. Ability to work independently and with a team.
  21. Ability to primarily work hours that conform to standard business operations (8:00 A.M. to 5:00 P.M.); however, may require extended work hours from time to time, or require shifted work hours from either 5:30 A.M. – 2:00 P.M. or 1:30 P.M. – 10:00 P.M..  May also require some weekend work as needed.
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