GMP QA Floor Lead & Compliance Specialist

BIO-TECHNE Corp; Minnesota; On-site; USD 56,000 - 91,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Short-term & long-term disability

401k with ESPP

HSA / FSA

Tuition reimbursement

Mentorship and career development

Job summary

Bio-Techne in Minnesota is seeking a QA Operations Specialist - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection for GMP products. The role includes reviewing Batch Records, disposition of materials, and supporting line changeovers and deviations.

Ideal candidates hold a Bachelor's in a scientific field, at least 3 years in GMP, and may have ASQ certification. You will collaborate with Operations, QC, Facilities, and Materials to drive compliance,

Qualifications

• 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.

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 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.

Skills

Attention to detail

Root cause analysis

Problem solving

Project management

Team leadership

Communication skills

Quality documentation

Education

Bachelor's degree in a relevant scientific field

Job description

Bio-Techne in Minnesota is seeking a QA Operations Specialist - Floor Support to provide on-the-floor QA oversight of manufacturing and visual inspection for GMP products. The role includes reviewing Batch Records, disposition of materials, and supporting line changeovers and deviations.

Ideal candidates hold a Bachelor's in a scientific field, at least 3 years in GMP, and may have ASQ certification. You will collaborate with Operations, QC, Facilities, and Materials to drive compliance,