QA On-the-Floor Lead: GMP & Manufacturing

Bio-Techne Corp.; Saint Paul (MN); On-site; USD 56,000 - 91,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with ESPP

Job summary

Bio-Techne Corp. in St. Paul, MN, seeks a QA Operations Specialist – Floor Support to provide on-the-floor QA oversight for GMP manufacturing and visual inspection activities in a fast-paced environment.

The role focuses on batch-record reviews, deviation handling, CAPA initiation, and product disposition, with opportunities to contribute to process improvements and regulatory audits.

Qualifications

• Bachelor’s degree in a relevant scientific field.
• Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality.
• ASQ certification is a plus.
• Exposure to RCA, technical writing, and working with quality-related investigations.

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.
• 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 SOPs 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.

Skills

GMP knowledge

Root cause analysis

Quality documentation

On-the-floor QA

Cross-functional communication

Documentation review

Education

Bachelor’s degree in a relevant scientific field

Tools

Microsoft Word

Microsoft Excel

Microsoft AX

Job description

Bio-Techne Corp. in St. Paul, MN, seeks a QA Operations Specialist – Floor Support to provide on-the-floor QA oversight for GMP manufacturing and visual inspection activities in a fast-paced environment.

The role focuses on batch-record reviews, deviation handling, CAPA initiation, and product disposition, with opportunities to contribute to process improvements and regulatory audits.