Advanced Quality Assurance Operations Specialist

Bio-Techne • St. Paul, MN

3d • $55,600 - $91,450 • Onsite

About The Position

The QA Operations Specialist – Floor Support provides Quality Assurance support for Manufacturing and Visual Inspection activities for clinical and commercial products in a GMP facility. The role provides on-the-floor Quality oversight of manufacturing activities, including observation of formulation and aseptic processes, AQL visual inspection of finished product vials, GMP documentation and batch record review, line clearance and product changeovers, disposition of incoming raw materials, and review and approval of facility work orders. It also monitors manufacturing-related systems and processes to support compliance with applicable regulatory and industry standards, quality improvements, and the safety and efficacy of phase-appropriate GMP manufacturing.

The specialist works with Operations, QC, Facilities/Engineering, Project Management, Materials Management, and other internal teams to address quality and operational issues. The position supports Quality Systems, investigations, audits, inspections, process improvements, and GMP documentation. Work is onsite during standard business hours, with schedule variation occasionally required by production needs.

Requirements

• Bachelor’s degree in a relevant scientific field.
• At least 3 years of experience in a relevant GMP industry, including at least 1 year of experience in Quality, or an equivalent combination of education and experience.
• Exposure to root cause analysis, technical writing, and quality-related investigations.
• Knowledge of applicable guidelines and regulations, including ISO 9001, ISO 13485, ISO 14971, 21 CFR Part 11, and 21 CFR Part 820.
• Attention to detail and organizational skills.
• Working knowledge of Microsoft Word and Excel.
• Computer entry, typing, or electronic document filing skills.
• Ability to work in a fast-paced environment requiring multitasking.
• Excellent verbal and written communication skills.
• Knowledge of technical, regulatory, quality, and production management systems.
• Knowledge of good documentation principles and processes.
• Accuracy, clarity, proofreading, problem-solving, root cause analysis, and sound evaluation of courses of action.
• Project management skills and skills in leading project teams or teams.
• Ability to coordinate with Manufacturing departments.
• Flexibility and ability to act independently on routine assignments or projects.
• Ability to plan, organize, and multitask to complete assignments efficiently.
• Ability to work independently and with a team.
• Ability to work hours that conform to standard business operations.
• Ability to work at a computer and stand and walk for extended periods.
• Ability to lift and handle materials weighing 5–20 lbs.

Nice To Haves

• ASQ certification.
• Exposure to lean operational excellence.
• Knowledge of FDA regulations, including 21 CFR Parts 210, 211, and 820, and some experience with international regulations such as ICH.
• Ability to apply basic scientific principles to solve operational and routine quality tasks.
• Experience with risk management tools such as FMEA, HACCP, or PHA, and familiarity with ICH Q9.
• Experience in design and development of protein and/or antibody expression and purification.
• Experience in design and development of molecular and CGT products.
• Experience communicating with customers or clients, both verbally and in writing.
• Knowledge of Microsoft AX.

Responsibilities

• Perform on-the-floor QA activities, including room release, critical-process audits, real-time GMP documentation review, and resolution of manufacturing issues.
• Consult with Operations, QC, Facilities/Engineering, Project Management, Materials Management, and other internal teams to resolve complex situations or problems.
• Conduct walkthroughs and internal audits of manufacturing and support areas to verify adherence to policies and procedures.
• Review batch records for compliance with internal procedures and Good Documentation Practices.
• Support evaluation and disposition of intermediates, bulk product, and finished product.
• Review, approve, and disposition incoming materials.
• Review and approve new and revised GMP documents, including SOPs and raw material specifications.
• Respond promptly to on-the-floor quality issues, document events and investigations, and implement required immediate corrective actions.
• Co-own nonconforming material investigations.
• Review Quality Control environmental and utility monitoring data and test results.
• Review and approve work orders that affect manufacturing facilities and utilities.
• Conduct root cause analysis using methods such as fishbone diagrams and 5 Whys.
• Advise and coach employees on proper documentation of tasks.
• Initiate Quality Systems records, including deviations, CAPA, and nonconformances.
• Perform Acceptable Quality Limit (AQL) visual inspection of final product and inspection of final product retains.
• Support visual inspection, packaging, and labeling operations.
• Create, review, and approve final product labels.
• Revise SOPs to support process improvements.
• Participate in site quality and process improvement initiatives, represent QA on project teams, and provide QA perspectives as needed.
• Support internal, customer, and regulatory audits and inspections.
• Guide personnel involved in GMP operations on cGMP compliance, internal procedures, regulatory requirements, and industry best practices.

Benefits

• Medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield insurance benefits starting on day one.
• 401(k) plan.
• Employee stock purchase plan (ESPP).
• Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Mentorship, promotional opportunities, training and development, and tuition reimbursement.
• Volunteer paid time off.
• Paid holidays, paid time off, and paid parental leave.
• Employee resource groups, employee events, and charity drives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level