Advanced Quality Assurance Operations Specialist

About the role

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.

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.
• undefined

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.