QA Technician II: Batch Records & Quality Assurance

NCBioImpact; North Carolina; On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Paid vacation

Healthcare

Dental coverage

Stock programs

Job summary

NCBioImpact is seeking a Quality Assurance professional to provide real-time quality support to manufacturing operations and to review Batch Production Records to ensure cGMP and regulatory compliance.

The role collaborates with Manufacturing, Packaging, Batch Release, and QA teams to ensure accurate documentation, proper sampling, and timely resolution of quality issues during shifts. This role requires strict attention to detail and experience with SAP and TrackWise in a fast-paced environment.

Qualifications

• High school diploma, GED, or equivalent with at least six months of relevant experience.
• Bachelor's degree preferred; related experience may substitute.
• Equivalent combination of education, training, and relevant experience.

Responsibilities

• Batch Production Record (BPR) reviews for completeness, accuracy, and cGMP compliance.
• Perform QA sampling and inspection of finished products per procedures and AQL.
• Manage retain samples and transfer to designated storage, including off-site locations.
• Evaluate samples from contract packaging and document results for Batch Release.
• Print and verify product labels; ensure accuracy before release.
• Maintain quality systems and documentation; initiate quality events in TrackWise.
• Provide QA support to Manufacturing and Packaging; approve packaging/production activities.
• Assure documentation is complete, accurate, legible, traceable, and compliant.

Skills

Attention to detail

Quality assurance

Documentation

Verbal and written communication

SAP

TrackWise

Microsoft Office

Education

High school diploma or GED

Bachelor's degree (preferred)

Tools

SAP

TrackWise

Job description

NCBioImpact is seeking a Quality Assurance professional to provide real-time quality support to manufacturing operations and to review Batch Production Records to ensure cGMP and regulatory compliance.

The role collaborates with Manufacturing, Packaging, Batch Release, and QA teams to ensure accurate documentation, proper sampling, and timely resolution of quality issues during shifts. This role requires strict attention to detail and experience with SAP and TrackWise in a fast-paced environment.