Night Shift QA Batch Record Reviewer/ Person in Plant, 4553936

Pharmaceuticals located in San Carlos is seeking a Quality Assurance Batch Record Reviewer / Person-In-Plant to support Quality oversight of manufacturing operations for the NIGHT SHIFT. This is a temporary assignment. Responsible for on-the-floor, timely and effective GMP review and production close-out of batch record documentation in order to maintain a continuous flow of batch records

Single point of contact in the plant during the assigned Manufacturing shift for the Batch Record Review Process and Quality matters.

Operates on a 8-hour shift (10:00pm-6:30am) to support 24x5 Operations.

• Responsibilities include approval and issuance of batch records, approving records; issue resolution; batch record review.

• Reviews batch documentation for accuracy and completeness according to cGMP’s to ensure timely release.

• Supports/performs scanning of records for uploading into share folders

• Conducts QA Person-In-Plant activities including, Area Approval, Line Clearance Approval, Batch Record Review, Deviation triage and preliminary investigation, etc.

• Assists with Deviation investigations, Compliance investigations, and Customer complaint investigations.

• Supports implementation of CAPAs, SOP revisions, Quality improvement initiatives, Operational Excellence projects, etc.

• Adheres to internal/external Guidelines, Specifications and Regulatory requirements while reviewing batch documentation.

• Ensures all GMP’s, SOP’s and protocols are followed.

• Positively interacts with internal associates to quickly and effectively resolve issues.

• Addresses deficiencies and ensures completion of follow-up actions, specifically those that target process fixes to maintain consistent resolutions to batch review issues according to GMP standards and Novartis objectives.

Skills:

• Minimum Requirements: MUST BE ABLE TO WORK NIGHT SHIFT 10:00pm-6:30am. First couple weeks of training will be day shift.

• 2-5 years related manufacturing or quality experience. BS degree in science in preferred.

• Demonstrated cGMP knowledge and experience.

• Strong interpersonal, written, communication, and problem solving skills.

• Must be well organized, flexible and able work with minimal supervision.

• Prior experience with Quality Assurance Batch Record Review and/or Person-In-Plant is preferred.

• Strong background and skills in Quality, Manufacturing, communication and computer related systems are preferred.

• Experience with Deviation Investigations and Root Cause Analysis is a plus.

• Experience with Microsoft Word / Excel, SAP and TrackWise is a plus.

• BS degree in science is preferred.

For more information, please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960