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

Artech 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.
• 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.

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.
• 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

Quality Assurance Batch Record Review

cGMP Knowledge

Problem Solving Skills

Interpersonal Communication

Organizational Skills

TrackWise

Root cause analysis

MS Word/Excel

Education

BS degree in science

Tools

Microsoft Word

Microsoft Excel

SAP

TrackWise

Job description

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

Contract

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

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

• 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 & Qualifications

• 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 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.