Batch Record Review Lead

4 days ago


Baltimore, Maryland, United States Medvacon Life Sciences Full time

Medvacon Life Sciences is seeking a highly experienced Batch Record Review Lead to join our Quality Assurance team. This role offers a competitive salary of $120,000 per year.

Job Description

The Batch Record Review Lead will oversee a team of consultants responsible for reviewing and compiling manufacturing records for our products. Key responsibilities include:

  • Leading a team of experts in batch record review, ensuring they meet assigned goals and deadlines.
  • Representing Quality Assurance in support of complex deviations, change controls, CAPAs, and investigations.
  • Providing consultation and advice on QA policies and procedures.
  • Reviewing and approving controlled documents, including raw material receipts, inspections, and shipping.
  • Evaluating processes and procedures for continuous improvement.

Requirements:

  • Minimum 6 years' experience in quality assurance and GMP in the pharmaceutical/biotech industry.
  • Bachelor's degree in a scientific discipline or similar education; advanced degree preferred.
  • Previous leadership/supervisory experience and strong problem-solving skills.
  • Attention to detail, organizational skills, and ability to prioritize multiple assignments.

This is an excellent opportunity for a motivated and experienced professional to lead our batch record review team. If you have a passion for quality assurance and a strong background in GMP regulations, we encourage you to apply.



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