Artech Information System LLC
Night Shift QA Batch Record Reviewer/ Person in Plant, 4553936
Artech Information System LLC, San Carlos, California, United States, 94071
Night Shift QA Batch Record Reviewer/ Person in Plant, 4553936
ContractPharmaceuticals 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; issue resolution; batch record review.Reviewing batch documentation for accuracy and completeness according to cGMP’s to ensure timely release.Scanning of records for uploading into share folders.Conducting QA Person-In-Plant activities including Area Approval, Line Clearance Approval, Batch Record Review, Deviation triage and preliminary investigation.Assisting with Deviation investigations, Compliance investigations, and Customer complaint investigations.Supporting implementation of CAPAs, SOP revisions, Quality improvement initiatives, Operational Excellence projects.Adhering to internal/external Guidelines, Specifications and Regulatory requirements while reviewing batch documentation.Ensuring all GMP’s, SOP’s and protocols are followed.Positively interacting with internal associates to quickly and effectively resolve issues.Addressing deficiencies and ensuring completion of follow-up actions targeting 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 of weeks of training will be day shift.2-5 years related manufacturing or quality experience. BS degree in science preferred.Demonstrated cGMP knowledge and experience.Strong interpersonal, written, communication, and problem-solving skills.Must be well organized, flexible and able to 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.
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ContractPharmaceuticals 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; issue resolution; batch record review.Reviewing batch documentation for accuracy and completeness according to cGMP’s to ensure timely release.Scanning of records for uploading into share folders.Conducting QA Person-In-Plant activities including Area Approval, Line Clearance Approval, Batch Record Review, Deviation triage and preliminary investigation.Assisting with Deviation investigations, Compliance investigations, and Customer complaint investigations.Supporting implementation of CAPAs, SOP revisions, Quality improvement initiatives, Operational Excellence projects.Adhering to internal/external Guidelines, Specifications and Regulatory requirements while reviewing batch documentation.Ensuring all GMP’s, SOP’s and protocols are followed.Positively interacting with internal associates to quickly and effectively resolve issues.Addressing deficiencies and ensuring completion of follow-up actions targeting 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 of weeks of training will be day shift.2-5 years related manufacturing or quality experience. BS degree in science preferred.Demonstrated cGMP knowledge and experience.Strong interpersonal, written, communication, and problem-solving skills.Must be well organized, flexible and able to 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.
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