We are currently looking to add a Quality Systems Specialist to our team in St. Cloud, MN. In this role, you will be responsible for supporting Microbiologics Quality System efforts as outlined below. Assisting in all aspects of the Quality Systems department, this including Document Control, as well as stand-alone projects as assigned and directed. Responsible for all Change Order processes and training.

What can I expect in this role?

In this position, you will work Monday – Friday 8am – 4:30 pm.

Some key duties in this role include:

• Assist and support Microbiologics Quality System efforts to meet FDA QSR requirements, ISO 13485, ISO 17025, ISO 17034, and CE Mark conformity.
• Perform Document Control functions and aid in assisting all employees with questions pertaining to all aspects of that system.
• Conduct special projects as needed.
• Be able to react when called upon to represent the Quality Systems department.
• Must be able to prioritize workload and schedule as needed to meet goals and deadlines.
• Facilitate meetings/teams for specialty projects and others as assigned.
• Act as mentor and backup to Quality Department Administrative Assistant during absences.
• Manage the Change Order process, including review and approval of change orders.
• Assist with CAPA system and perform CAPA Verifications.
• Initiate Electronic Change Orders with follow through on document processing, training and all actions as required
• Monitor standards for updates.
• Manage and monitor equipment for Calibration and Preventive Maintenance.
• Manage FDA Certificates to Foreign Government and Apostle/Legalization requests.
• Complete supplier qualification surveys for potential/existing customers.
• Perform Document Control Administration and Primary Analyst for Electronic Change Order and Document processing.
• Mentor and Train employees on Document Control requirements, Change Orders and cGMP.
• Maintain Technical Files of required documents for regulatory communication.
• Manage the Deviation Process.
• Filing / File maintenance for Quality Control department including Production and Laboratory documents, and Employee Training Files.
• Maintain the necessary active and archiving of documentation as set by the facilities Quality System.
• Maintain metrics and communication board.
• Review and maintain pest control records.
• Maintain Safety Data Sheets for on-line computer access.
• Maintain all Binders.
• Scan Molecular documents and maintain electronic files for Molecular department.
• Update Organization Charts of all departments within the company.

What makes you a good fit?

Our goal is finding the right individual for our team – we firmly believe that the right person is someone to invest in and invite to join our family. 

Here is what we are looking for:

• High School education or equivalent required.
• Two/Four year Engineering/Technical degree preferred.
• 5 years previous related experience and/or training preferred.
• Experience with ISO standards preferred.
• Experience with Auditing, report writing, technical writing, document proofing, basic understanding of various types of equipment, both manufacturing and measurement preferred.
• Presentation, training, and measurement experience preferred.
• The ability to pass a background check and drug screening.

Who is Microbiologics?

Microbiologics is one of the fastest growing international biotechnology companies in the nation. We are the world’s leading experts and go-to collaborators in biological products and services, focused on protecting the health and safety of people around the world. For over 50 years, we have been partnering with healthcare and life science laboratories, manufacturers, and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics, and virology. Headquartered in Saint Cloud, Minnesota, we have additional facilities in California, Kentucky, and Michigan.

Our award-winning culture is friendly, collaborative, and supportive, providing endless opportunities for individuals to learn and grow, both personally and professionally. At Microbiologics, we believe that "great vision without great people is irrelevant." That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world.

What can we offer you?

Glad you asked!

We have a comprehensive benefits package that includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long-term disability, and a 401k program with a generous match to name a few. In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and growth. 

If you have a passion for science, we encourage you to apply!