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 ...
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 ...
Batch Record Specialist
Bloomington, IN · On-site
This role will be responsible for reviewing executed batch records and manufacturing documentation to ensure compliance with cGMP requirements, regulatory standards, and internal procedures. The ...
Quick apply
Batch Record Specialist
Bloomington, IN · On-site
This role will be responsible for reviewing executed batch records and manufacturing documentation to ensure compliance with cGMP requirements, regulatory standards, and internal procedures. The ...
Batch Record Coordinator
Tustin, CA · On-site
$16.68 - $22.26/hr
You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also ...
Batch Record Coordinator
Tustin, CA · On-site
$16.68 - $22.26/hr
You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also ...
Batch Record Coordinator
Tustin, CA · On-site
$16.68 - $22.26/hr
You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also ...
Batch Record Coordinator
Tustin, CA · On-site
$16.68 - $22.26/hr
You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also ...
Batch Record Coordinator
Tustin, CA · On-site
$16.68 - $22.26/hr
You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also ...
Batch Record Coordinator
Tustin, CA · On-site
$16.68 - $22.26/hr
You'll compile and review data, support manufacturing activity planning, and swiftly resolve issues. Coordinate controlled documents, training packets, and batch record preparation, while also ...
Manufacturing Batch Record Coordinator
$57K - $107K/yr
Reviews all batch documentation for accuracy and completeness according to cGMP's to ensure timely release. * Ensures deviations are initiated for any batch record review related events Find ...
Manufacturing Batch Record Coordinator
$57K - $107K/yr
Reviews all batch documentation for accuracy and completeness according to cGMP's to ensure timely release. * Ensures deviations are initiated for any batch record review related events Find ...
A Day in the Life • Perform comprehensive batch record review to support product release in compliance with GMP and regulatory requirements • Ensure all documentation, deviations, and ...
A Day in the Life • Perform comprehensive batch record review to support product release in compliance with GMP and regulatory requirements • Ensure all documentation, deviations, and ...
A Day in the Life • Perform comprehensive batch record review to support product release in compliance with GMP and regulatory requirements • Ensure all documentation, deviations, and ...
A Day in the Life • Perform comprehensive batch record review to support product release in compliance with GMP and regulatory requirements • Ensure all documentation, deviations, and ...
Review completed batch records, routers, inspection records, equipment logs, and supporting documentation for completeness, legibility, accuracy, required signatures, dates, and compliance with ...
New
Review completed batch records, routers, inspection records, equipment logs, and supporting documentation for completeness, legibility, accuracy, required signatures, dates, and compliance with ...
New
Batch at RPM Medina, Ohio
Medina, OH · On-site
$16 - $19.50/hr
Temporary Batch Maker Republic Powdered Metals, Inc. (RPM), founded in 1947 and based in Medina ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
New
Batch at RPM Medina, Ohio
Medina, OH · On-site
$16 - $19.50/hr
Temporary Batch Maker Republic Powdered Metals, Inc. (RPM), founded in 1947 and based in Medina ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
New
Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
Batch Maker
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
Medina, OH · On-site
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
Medina, OH · On-site
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Are you resilient? The Master Batch Record (MBR) Designer will be presented with hard work ... Subject to motor vehicle report review. * Maintain valid driver's license and endorsements as ...
Are you resilient? The Master Batch Record (MBR) Designer will be presented with hard work ... Subject to motor vehicle report review. * Maintain valid driver's license and endorsements as ...
Are you resilient? The Master Batch Record (MBR) Designer will be presented with hard work ... Subject to motor vehicle report review. * Maintain valid driver's license and endorsements as ...
Quick apply
Are you resilient? The Master Batch Record (MBR) Designer will be presented with hard work ... Subject to motor vehicle report review. * Maintain valid driver's license and endorsements as ...
Batch Maker
Medina, OH · On-site
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
Medina, OH · On-site
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
Medina, OH · On-site
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Batch Maker
Medina, OH · On-site
$16 - $19.50/hr
We are currently looking for an individual to fill a Temporary Batch Maker position at our ... Demonstrated safe work record. * Demonstrated reliable attendance. Qualified applicants will ...
Review and sign batch records and manufacturing documents/ procedures as needed * Supports Operations, Quality Control, Quality Assurance and Program Management teams by providing expertise and ...
Review and sign batch records and manufacturing documents/ procedures as needed * Supports Operations, Quality Control, Quality Assurance and Program Management teams by providing expertise and ...
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Night Shift QA Batch Record Reviewer/ Person in Plant, 4553936
San Carlos, CA • On-site
Contractor
Re-posted 25 days ago
Job description
Company Description
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.
Job Description
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.
Qualifications
BS degree in science is preferred.
Additional Information
For more information, please contact
Akriti Gupta
(973) 967-3409
Morristown, NJ 07960
About Artech
Sourced by ZipRecruiter
Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).
Industry
Recruiting and staffing services
Company size
10,000+ Employees
Headquarters location
Morristown, NJ, US
Year founded
1992