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Batch Record Coordinator

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  • Proactively organizes and reviews all regulatory manufacturing records within one working day of manufacturing.  
  • Track and document any issues with Good Documentation Practices and work with production Supervision to expedite any necessary corrections, including support of training/retraining activities related to SOPs, documentation, etc.
  • Works with the ESC Record Center to help complete record retention activities for ESC batch records, as required.
  • May interact with multiple functions, including: Process Engineering, Production Planning, Operations, R&D Package and Process Engineering. 
  • Audit production records for compliance with Good Manufacturing Practices and achieve constant state of “audit readiness” for all production documentation.
  • Interfaces with Production Management, GMP auditors and others in participating in root cause analysis and fault finding when identifying, investigating and correcting batch record problems
  • Maintain accountability records for production and labeling and reconcile batch record discrepancies.
  • Ensure batch records have all required documents such as MBRs, PBRs, process charts among others 
  • Proactively apply detailed process knowledge to continuously improve production processes, including but not limited to addressing Nonconformities and entering root cause / corrective actions for identified issues
  • Use SAP for production transactions such as production release and assigning batch codes to production orders.
  • Work with QA to release completed batch records in a timely manner.
  • Prepare new hire packets for new employees.
  • Assist Supervisors with annual operator refresher training requirements.

 

Qualifications

  • High School diploma or equivalent required. Associate degree or bachelor’s degree preferred.
  • The candidate should have knowledge of and demonstrated proficiency in computer software applications, including Microsoft Excel.  Candidate must be able to learn customized computer software.
  • Must have successfully completed Better Process Control School or plan to complete within 90 days of hiring date
  • Experience with Optiva is highly preferred.  Experience with SAP desired
  • Working knowledge of ESC Manufacturing documentation is highly preferred.
  • Demonstrated high level of personal accountability with strong organizational and follow-up skills.  
  • Demonstrated effective verbal and written communication skills and demonstrates a strong attention to detail.  Accuracy with proof-reading and data entry is critical.
  • Demonstrated ability to effectively manage multiple tasks to meet business objectives in a fast-paced environment. 
  • Proactively apply detailed process knowledge to continuously improve production processes.
  • Experience in a heavily regulated production environment
  • Experience working with regulatory bodies (e.g. TGA, FDA etc.) with exposure to regulatory audits
  • Experience with production or process improvement initiatives
  • Experience with working in a team environment, working with many levels of internal and external customers with minimal supervision.
  • Experience with administering or developing systems to manage documentation or information.

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Nearest Major Market: Evansville

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