Batch Records Specialist

Support Specialists are available to cover the following shifts:

• 1st Shift (Day): 7:00 AM – 3:00 PM EST
• 2nd Shift (Evening): 3:00 PM – 11:00 PM EST
• 3rd Shift (Night): 11:00 PM – 7:00 AM EST

• Accurately enter and verify batch record documentation during manufacturing operations in alignment with approved master batch records.
• Perform and double-check calculations within batch records to ensure accuracy, completeness, and compliance with GDP and cGMP requirements.
• Guide manufacturing operators on proper documentation practices
  , ensuring real-time, compliant, and legible batch record entries.
• Review in-process documentation to ensure all required steps, checks, and signatures are completed before batch progression.
• Identify, document, and escalate documentation discrepancies or gaps to Quality or Manufacturing leadership in a timely manner.
• Support organization, tracking, and retrieval of batch documentation for audits, inspections, and internal reviews.
• Provide on-the-floor documentation support and coaching
  , reinforcing GDP, cGMP, and site documentation standards in a fast-paced production environment.