Quality Assurance Specialist II - GMP/Medical Devices

SSI Diagnostica Group; Radford (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

TechLab, part of SSI Diagnostica Group, seeks a Quality Assurance Officer II to uphold quality systems across operations. You will review documentation for regulatory compliance, manage CAPA activities, and supervise change controls while coordinating with Production, QC, and other departments.

The role requires problem-solving, strong attention to detail, and effective communication to ensure patient-safe outcomes in a fast-paced diagnostics manufacturing environment.

Qualifications

• Must have experience in a controlled manufacturing environment and quality system
• Experience reviewing documentation for accuracy and regulatory compliance
• Familiarity with CAPA processes and investigations
• Ability to manage multiple tasks and document control procedures

Responsibilities

• Issue and review MBRs in support of Production schedule
• Approve lot expirations for materials and finished products
• Create, review and apply QA release labels
• Review QC results per SOPs, RMSs, and PRSs
• Ensure controlled documents are issued and retrievable
• Initiate and verify DCRs and SCRs for changes
• Perform visual inspection and AQL testing of materials
• Identify non-conformities and manage CAPA
• Deliver new hire training
• Complete projects as directed by QA leadership

Skills

Attention to detail

Problem solving

Cross-functional collaboration

Verbal and written communication

Education

Bachelor's degree in Life Sciences or related

Associate's degree + 3 years GMP experience

Master's degree + 1 year GMP experience

Tools

ERP system

Electronic quality systems

Change control systems

Job description

TechLab, part of SSI Diagnostica Group, seeks a Quality Assurance Officer II to uphold quality systems across operations. You will review documentation for regulatory compliance, manage CAPA activities, and supervise change controls while coordinating with Production, QC, and other departments.

The role requires problem-solving, strong attention to detail, and effective communication to ensure patient-safe outcomes in a fast-paced diagnostics manufacturing environment.