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…