Advanced Quality Assurance Operations Specialist

Bio-Techne • Saint Paul, MN

1d • Onsite

About The Position

The QA Operations Specialist – Floor Support provides Quality Assurance support for Manufacturing and Visual Inspection activities involving clinical and commercial products in a GMP facility. The position provides on-the-floor quality oversight of manufacturing activities, including 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, facility work-order review and approval, and other QA functions. The role continuously monitors manufacturing-related systems and processes to support regulatory and industry compliance, quality improvement, and the safety and efficacy of phase-appropriate GMP product manufacturing.

The specialist collaborates with Operations, QC, Facilities/Engineering, Project Management, and Materials Management, and supports investigations, quality-system activities, audits, inspections, and process-improvement initiatives. The role coaches personnel on documentation and GMP compliance and may guide staff involved in GMP operations.

The position requires a relevant scientific bachelor’s degree and at least three years of relevant GMP-industry experience, including at least one year in Quality, or an equivalent combination of education and experience. Work is onsite during standard business hours, with occasional schedule variation according to production needs. Physical activities include extended computer use, standing and walking, and handling materials weighing 5–20 pounds.

Requirements

• Bachelor’s degree in a relevant scientific field, or an equivalent combination of education and experience.
• At least three years of experience in a relevant GMP industry, including at least one year of Quality experience, unless satisfied through an equivalent combination of education and experience.
• Knowledge of FDA regulations, including 21 CFR Parts 210, 211, and 820, and some experience with international regulations such as ICH.
• Knowledge of applicable guidelines and regulations, including ISO 9001, ISO 13485, ISO 14971, 21 CFR 11, and 21 CFR 820.
• Ability to apply basic scientific principles to operational and routine quality tasks.
• Required attention to detail, organizational skills, working knowledge of Microsoft Word and Excel, and computer entry, typing, or electronic document-filing skills.
• Excellent verbal and written communication skills, including professional communication and proofreading.
• Ability to work in a fast-paced environment requiring multitasking, plan and organize work, and complete assignments efficiently and accurately.
• Ability to work independently and as part of a team, act independently on routine assignments, and remain flexible.
• Ability to work hours conforming to standard business operations.
• Ability to work at a computer for extended periods, stand and walk for extended periods, and lift and handle materials weighing 5–20 pounds.

Nice To Haves

• ASQ certification.
• Exposure to root cause analysis, technical writing, and quality-related investigations.
• Exposure to lean operational excellence.
• Experience using 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.
• Customer or client communication experience, written and verbal.
• Experience with Microsoft AX.
• Skills in project management, leading project teams or teams, and coordinating with Manufacturing departments.

Responsibilities

• Provide QA floor support for manufacturing projects, including room release, audits of critical processes, real-time GMP documentation review, and resolution of manufacturing issues.
• Consult and coordinate with Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems.
• Conduct frequent walkthroughs and internal audits of manufacturing and support areas to check compliance with 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 ensure required immediate corrective actions are taken.
• Co-own nonconforming material investigations and initiate quality-system records, including deviations, CAPA, and nonconformances.
• 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 task documentation and GMP compliance.
• Perform AQL visual inspection of final product and support visual inspection, packaging, and labeling operations.
• Create, review, and approve final product labels and inspect final product retains.
• Revise SOPs as needed to support process improvements and 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) plans.
• Employee stock purchase plan (ESPP).
• Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Mentorship, promotional opportunities, training and development, and internship programs.
• Tuition reimbursement.
• Employee resource groups, paid volunteer time off, employee events, and charity drives.
• Accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

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