QA Technician II: Batch & Compliance Expert

Regulatory Jobs; High Point (NC); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Paid vacation

Healthcare

Dental coverage

Stock programs

Job summary

Regulatory Jobs in High Point, NC seeks a Quality Assurance professional to support manufacturing operations, review Batch Production Records for cGMP compliance, and ensure documentation accuracy across SOPs and work instructions.

This role collaborates with Manufacturing, Packaging, Batch Release, and QA teams to resolve issues, perform product sampling, manage retain samples, and support label control, systems documentation, and continuous improvement in a fast-paced plant environment.

Qualifications

• FDA cGMP knowledge applicable to pharmaceutical manufacturing.
• Ability to read, interpret, and follow SOPs and Work Instructions.
• Strong attention to detail for documentation accuracy and compliance.
• Experience with QA documentation and record-keeping in GMP settings.
• Proficiency with Microsoft Office and ERP systems (SAP).

Responsibilities

• Review Batch Production Records for completeness and cGMP compliance.
• Perform QA sampling and inspection of finished products per procedures.
• Manage retain samples and transfer to appropriate storage or archive.
• Support contract packaging quality evaluations and related documentation.
• Print and verify labels; ensure accuracy before release.
• Initiate quality events and maintain quality-system records in TrackWise.
• Provide QA support to Manufacturing and Packaging operations; resolve quality questions.

Skills

cGMP knowledge

SOP proficiency

Documentation review

SAP

TrackWise

QA sampling

Microsoft Office

Attention to detail

Education

High school diploma

Bachelor's degree

Equivalent education/experience

Tools

SAP

TrackWise

Job description

Regulatory Jobs in High Point, NC seeks a Quality Assurance professional to support manufacturing operations, review Batch Production Records for cGMP compliance, and ensure documentation accuracy across SOPs and work instructions.

This role collaborates with Manufacturing, Packaging, Batch Release, and QA teams to resolve issues, perform product sampling, manage retain samples, and support label control, systems documentation, and continuous improvement in a fast-paced plant environment.