Advanced Quality Assurance Operations Specialist
BIO-TECHNE Corp
November 10, 2026
Full-time
On-site
St. Paul, MN
Operations
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:
$55,600.00 - $91,450.00
Position Summary:
The QA Operations Specialist – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial products in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities, including observing formulation and aseptic processes, performing AQL visual inspection of finished product vials, GMP documentation and Batch Record review, line clearance and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real-time continuous monitoring of manufacturing-related systems and processes to ensure compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase-appropriate GMP manufacture of products.
Key Responsibilities:
Perform QA on-the-floor activities supporting projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing.
Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems.
Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures. May include management from groups such as Operations, Facilities, Quality, and Materials Management.
Batch record review for adherence to internal procedures and Good Documentation Practices
Support the evaluation and disposition of intermediates, bulk product, and finished product.
Review, approve, and disposition incoming materials.
QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications.
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
Co-ownership of nonconforming material investigations.
Review of Quality Control environmental and utility monitoring data and test results
Review and approval of work orders impacting manufacturing facilities and utilities
Root cause analysis using methodologies, such as fishbone, 5 whys, etc.
Advise and coach internal-departmental employees on proper documentation of tasks.
Initiation of Quality Systems (deviations, CAPA, Nonconformances).
Perform Acceptable Quality Limit (AQL) visual inspection of final product
Support Visual Inspection, packaging, and labeling operations
Create, review, and approve final product labels
Perform inspection of final product retains
SOP revision as it pertains to process improvements.
Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA’s perspective as necessary.
Support internal, customer, and regulatory audits and inspections.
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
QUALIFICATIONS
Education and Experience:
Required:
Bachelor’s degree in a relevant scientific field.
Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience.
ASQ certification is a plus
Exposure to RCA, technical writing, and working with quality-related investigations
Preferred
Exposure to lean operation excellence highly desirable
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Knowledge, Skills, and Abilities:
Experience in design and development of protein and/or antibody expression and purification is preferred
Experience in design and development of molecular and CGT products is preferred.
Experience in Customer or Client communication, both written and verbal, is preferred.
Knowledge of applicable guidelines and regulations, namely ISO 9001, ISO 13485, ISO 14971, 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 required
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 evaluating a course of action
Skills in managing projects.
Skills in leading project teams or teams.
Skills in coordination with Manufacturing departments
Ability to be flexible.
Ability to act independently on routine assignments or projects.
Ability to plan, organize and multi-task to complete assignments in an efficient manner.
Ability to communicate professionally, both oral and written.
Ability to pay attention to details and perform at a high-level accuracy.
Ability to work independently and with a team.
Ability to work hours that conform to standard business operations
Working Conditions:
Standard schedule hours with occasional variation depending on production needs.
Onsite work required during standard business hours.
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Physical Requirements:
Ability to work at a computer for extended periods.
Ability to stand and walk for extended periods.
Ability to lift and handle materials weighing 5–20 lbs.
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, 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 offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
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.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.
Pay Range:
$55,600.00 - $91,450.00
Position Summary:
The QA Operations Specialist – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial products in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities, including observing formulation and aseptic processes, performing AQL visual inspection of finished product vials, GMP documentation and Batch Record review, line clearance and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real-time continuous monitoring of manufacturing-related systems and processes to ensure compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase-appropriate GMP manufacture of products.
Key Responsibilities:
Perform QA on-the-floor activities supporting projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing.
Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems.
Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures. May include management from groups such as Operations, Facilities, Quality, and Materials Management.
Batch record review for adherence to internal procedures and Good Documentation Practices
Support the evaluation and disposition of intermediates, bulk product, and finished product.
Review, approve, and disposition incoming materials.
QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications.
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
Co-ownership of nonconforming material investigations.
Review of Quality Control environmental and utility monitoring data and test results
Review and approval of work orders impacting manufacturing facilities and utilities
Root cause analysis using methodologies, such as fishbone, 5 whys, etc.
Advise and coach internal-departmental employees on proper documentation of tasks.
Initiation of Quality Systems (deviations, CAPA, Nonconformances).
Perform Acceptable Quality Limit (AQL) visual inspection of final product
Support Visual Inspection, packaging, and labeling operations
Create, review, and approve final product labels
Perform inspection of final product retains
SOP revision as it pertains to process improvements.
Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA’s perspective as necessary.
Support internal, customer, and regulatory audits and inspections.
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
QUALIFICATIONS
Education and Experience:
Required:
Bachelor’s degree in a relevant scientific field.
Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience.
ASQ certification is a plus
Exposure to RCA, technical writing, and working with quality-related investigations
Preferred
Exposure to lean operation excellence highly desirable
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Knowledge, Skills, and Abilities:
Experience in design and development of protein and/or antibody expression and purification is preferred
Experience in design and development of molecular and CGT products is preferred.
Experience in Customer or Client communication, both written and verbal, is preferred.
Knowledge of applicable guidelines and regulations, namely ISO 9001, ISO 13485, ISO 14971, 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 required
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 evaluating a course of action
Skills in managing projects.
Skills in leading project teams or teams.
Skills in coordination with Manufacturing departments
Ability to be flexible.
Ability to act independently on routine assignments or projects.
Ability to plan, organize and multi-task to complete assignments in an efficient manner.
Ability to communicate professionally, both oral and written.
Ability to pay attention to details and perform at a high-level accuracy.
Ability to work independently and with a team.
Ability to work hours that conform to standard business operations
Working Conditions:
Standard schedule hours with occasional variation depending on production needs.
Onsite work required during standard business hours.
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Physical Requirements:
Ability to work at a computer for extended periods.
Ability to stand and walk for extended periods.
Ability to lift and handle materials weighing 5–20 lbs.
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, 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 offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
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.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.