Night-Shift QA Batch Recorder - GMP & Compliance

Artech Information System LLC; San Carlos (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

A leading IT staffing company in San Carlos is seeking a Night Shift QA Batch Record Reviewer to ensure manufacturing operations meet quality standards through timely and effective GMP reviews. The successful candidate will work 10:00 pm to 6:30 am, overseeing batch record reviews and quality documentation. A BS degree in science and 2-5 years of relevant experience are preferred, along with strong interpersonal and problem-solving skills. This is a temporary assignment requiring flexibility and organization.

Qualifications

• 2-5 years related manufacturing or quality experience.
• Prior experience with Quality Assurance Batch Record Review preferred.
• Experience with Deviation Investigations and Root Cause Analysis is a plus.

Responsibilities

• Approval and issuance of batch records; issue resolution.
• Reviews batch documentation for accuracy and completeness.
• Conducts QA Person-In-Plant activities and assists with investigations.

Skills

Quality Assurance Batch Record Review

cGMP Knowledge

Problem Solving Skills

Interpersonal Communication

Organizational Skills

Education

BS degree in science

Tools

Microsoft Word

Microsoft Excel

SAP

TrackWise

Job description

A leading IT staffing company in San Carlos is seeking a Night Shift QA Batch Record Reviewer to ensure manufacturing operations meet quality standards through timely and effective GMP reviews. The successful candidate will work 10:00 pm to 6:30 am, overseeing batch record reviews and quality documentation. A BS degree in science and 2-5 years of relevant experience are preferred, along with strong interpersonal and problem-solving skills. This is a temporary assignment requiring flexibility and organization.