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QA Batch Record Reviewer

Company: Automated Systems Inc.
Location: Waukegan
Posted on: November 15, 2021

Job Description:

The QA Batch Record Reviewer will use site specific Electronic Resource Planning (ERP) systems and other systems to review and approve finished product documentation and records. The position requires a thorough working knowledge of databases and computer software. Attention to detail is critical for success, as well as being able to work at a high pace while maintaining accuracy.The ideal candidate must possess a comprehensive knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) and the relation of these concepts to production records.6 month+ contract role with potential extensionsESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Operate in accordance and compliance with current cGMP regulations and ICH Q7 guidelines.Perform the following responsibilities in support of product release:
    • Batch Record Review - Review and approve all applicable GMP records associated with the manufacture and release of Active Pharmaceutical Ingredients and Excipients.
      • Batch record review and release of incoming raw materials, intermediates, finished products and cleaning procedures for all Excipient and API business. Working closely with manufacturing to ensure GMP/GDP practices.
        • Log sheet reviews of all equipment used during product manufacturing and analytical data package review as a part of batch record release.
          • Ensure that manufacturing and laboratory personnel are properly trained for the tasks performed through training record review.
            • Equipment utilized during manufacturing has been properly qualified / calibrated / validated.
              • Data documentation and corrections to documentation are properly executed in compliance with cGMP Good Documentation Practices.Critically reviews GMP documents such as: ---o Executed batch records for a variety of different functional areaso Analytical Testing Datao Microbial and Environmental Monitoring Datao WFI testing datao Equipment Datao Logbooks
                • Performs transactions which may include QA disposition of Intermediate Clinical and Commercial product for further manufacturing.
                  • Work on issues where analysis of situations or data requires an evaluation of multiple inputs.
                    • Resolve complex issues in creative and effective ways using a wide range of experience, professional concept and company objectives.
                      • Frequently interact with direct manager, subordinates, internal customers and other cross functional peers to gain alignment on sound quality decisions.
                        • Initiate non-conformance investigations
                          • Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
                            • Act in a trainer capacity for Batch Review activities for New Employees
                              • Review and Revise SOPs and Relevant Documents using Electronic DMSQuality Operations Support:
                                • Compile and communicate performance metrics and data trend analyses to senior management for Batch Review and Release relevant activities.Continuous Improvement
                                  • Identify opportunities for improvement within scope of work.
                                    • Serves as change agent for continuous improvement in operational excellence activities.Regulatory Inspection
                                      • Provide logistical support and technical knowledge during regulatory and internal inspections of Emergent quality systems.Requirements:Education and Experience Requirements:
                                        • BS or BA degree in Science or Engineering with 3-10 years of GMP experience with at least one year in an FDA regulated industry.Qualifications:
                                          • Excellent Computer skills - Microsoft Office software and databases, ability to use computer programs such as an electronic document management system.
                                          • Working knowledge of the cGMP regulations (ICH Q7).
                                          • Motivation, attention to detail are essential with strong leadership skills.
                                          • Good observation, organization, prioritization and problem-solving skills and the ability to make sound decisions regarding compliance-related issues with limited supervision.
                                          • Must demonstrate effective communication skills, technical writing ability and excellent written and verbal skills.
                                          • Ability to manage multiple priorities and tasks in a dynamic team environment.Physical Requirements:
                                            • Must have good hearing and sight - adequate for safety programs in a pharmaceutical manufacturing plant.
                                              • Must be able to sit and/or stand for extended periods.
                                                • Ability to work effectively under pressure to meet deadlines.
                                                  • Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, and listening.
                                                    • Must be able to lift 50 lbs.
                                                      • Ability to wear proper safety equipment when working in plant.Job Types: Full-time, ContractPay: $10.00 - $41.00 per hourSchedule:
                                                        • 8 hour shiftWork Location: One location

Keywords: Automated Systems Inc., Waukegan , QA Batch Record Reviewer, Other , Waukegan, Illinois

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