Piper Companies is currently seeking a QA Specialist, Manufacturing Batch Record Review for an opportunity in Summit, NJ to join a global biopharmaceutical company delivering life-saving medicines to patients with serious diseases.

Responsibilities of the QA Specialist, Manufacturing Batch Record Review

• Responsible for accurate and timely review and release of manufacturing batch records and other pertinent documents and records used at a manufacturing and testing facility in accordance with policies, standards, procedures and Global cGMPs
• Reviews executed batch records for documentation completeness and accuracy
• Obtains any identified GMP/GDP batch record corrections from manufacturing personnel
• Communicates effectively with other departments within the organization and functions well within a team environment

Qualifications of the QA Specialist, Manufacturing Batch Record Review

• 1+ years of experience working in a cGMP environment
• Possesses strong interpersonal and time management skills, and the abilities to work well in a team environment and coordinate multiple tasks efficiently
• Hands-on experience with batch record review and product disposition preferred
• High school diploma required, bachelor's degree preferred

Compensation for the QA Specialist, Manufacturing Batch Record Review

• Salary Range: $42 - $45 / hour
• Benefits: Comprehensive; Medical, Dental, Vision, 401k, and PTO
• Contract Opportunity

Keywords: cGMP, current good manufacturing practice, biopharmaceutical, pharma, environmental monitoring, monitoring, QC, quality control, analyst, associate, microbiology, FDA, EMA, Food and Drug Administration, European Medicines Agency, testing, walk throughs, gram staining, pH, conductivity, patient material receipt, drug product, distribution, preventative maintenance, batch record review, GLP, GMP, good manufacturing practice