Quality Control Specialist: Precision Testing & Compliance

Roche; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

Roche in the United States seeks a Quality Control Associate to perform raw material and finished goods testing, review and sign-off quality documentation. You will work in an ISO 13485 and cGMP manufacturing environment, maintaining equipment, records and the laboratory environment to ensure regulatory compliance with SOPs.

The role involves investigating Out of Specification results, maintaining traceable records, and supporting continuous improvement while coordinating with cross-functional

Qualifications

• Experience performing inspection and testing of materials and finished goods.
• Ability to document test results and generate batch records.
• Familiarity with regulatory requirements (FDA, QSR, ISO) and GMP practices.

Responsibilities

• Perform inspection and testing of raw materials, in-process materials and finished goods in a compliant manner.
• Document test results, complete batch records, document observations and generate reports for qualification testing.
• Conduct data analysis of raw material, in-process and finished goods test results.
• Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods.
• Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements.
• Performs routine maintenance of laboratory equipment outlined by operating procedures.
• May assist in coordinating vendor activities for user maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Formulate reagents with high complexity for material testing process.
• Acts as QC representative in transferring processes from development to QC.
• May assist in testing raw materials for reliability and stability,in process monitoring and trending,in collecting, interpreting and communicating process metrics for recommended improvements.

Skills

Quality control

Documentation

Regulatory compliance

OOS investigations

Tools

Laboratory equipment

Job description

Roche in the United States seeks a Quality Control Associate to perform raw material and finished goods testing, review and sign-off quality documentation. You will work in an ISO 13485 and cGMP manufacturing environment, maintaining equipment, records and the laboratory environment to ensure regulatory compliance with SOPs.

The role involves investigating Out of Specification results, maintaining traceable records, and supporting continuous improvement while coordinating with cross-functional