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QA Batch Record Reviewer

Company: Automated Systems, Inc.
Location: Waukegan
Posted on: November 16, 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 extensions ESSENTIAL DUTIES AND RESPONSIBILITIES: --- Operate in accordance and compliance with current cGMP regulations and ICH Q7 guidelines. P erform 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 a nalytical 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 areas o Analytical Testing Data o Microbial and Environmental Monitoring Data o WFI testing data o Equipment Data o 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 DMS Quality 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. Job Requirements:

  • Interact collaboratively with members of the bariatric and hospital teams to identify areas for quality improvement and other projects
  • Met and supported throughout Clinical Review's standard operating procedures
  • Conduct reviews of home health clinical records for accuracy of OASIS, compliance with The Joint Commission and Medicare Conditions of Participation rulings, and compliance with evidenced based standards
  • Seek guidance on only the most complex tasks This position will require strong critical thinking, analytical and research skills along with the ability
  • Elevate appeals to the appropriate committee and/or manager per protocol +
  • Review, complete and securely deliver reports to the specified client in a timely manner
  • Work closely with both clinical and administrative staff and participate in at least two Metabolic Bariatric Surgery (MBS) Committee meetings
  • Conduct medical reviews for initial approval or appeals for a healthcare plan
  • Develop and maintain positive business relationships with community organizations, medical groups and regulatory agencies and participate in EmblemHealth community sponsored events to promote EmblemHealth's involvement with health improvement
  • Promote and maintain harmonious and effective relationships and communications with other departments and clients
  • Manage Risk - Basic Experience
  • Perform Pre-service utilization and concurrent reviews using Milliman criteria for Standard and Expedited Medicare member appeals in a fast-paced environment
  • Support activity with the CHRISTUS Health facilities and the Clinical Appeals Nurses
  • Handle the clinical review of appeals and will be responsible for completing standard member appeals
  • Interpret customer needs and requirements
  • Communicating, documenting and tracking of requests for formulary exceptions, prior authorization, and quantity exceptions, and brand override processes for delegated utilization management (UM) products
  • Obtaining necessary clinical documentation from provider
  • Participating in the appeal letter process
  • Maintain current knowledge of Federal, State, and local funding along with community resources
  • Participate in algorithm development and management with PDIP's analytic department and clinical team

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

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