Batch Record Review Specialist

4 weeks ago

Rockville, United States Insight Global Full time

One of our large Pharmaceutical clients is seeking a Batch Record Review Specialist to support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be a key member of the Quality Assurance team, providing guidance and expertise in the areas of batch record review and quality oversight, as well as compliance with cGMP requirements. Responsibilities include:

  • Conducting thorough reviews of batch records to ensure compliance with regulatory requirements and industry standards, supporting the production of high-quality pharmaceutical products
  • Ensure all discrepancies, deviations, and non-conformances are properly documented, investigated, and resolved before batch release
  • Collaborate with manufacturing, quality control, and other departments to ensure batch records meet all quality and compliance standards
  • Assist in the development and implementation of quality assurance processes and procedures to enhance batch record accuracy and completeness
  • Support internal audits and regulatory inspections, providing necessary documentation and responses related to batch record reviews
  • Ensure compliance with cGMP requirements and FDA regulations for the manufacture of pharmaceuticals.


Qualifications:

  • Bachelor’s Degree in a Science, Engineering, or related field of study
  • Minimum 3 years of experience in pharmaceutical manufacturing within cell & gene therapy
  • Minimum 5 years of related batch record review experience
  • Strong experience with deviations, OOS (Out of Specification), and CAPAs


Pay: $45.00-$50.00/hr (flexible based on experience)

Hours: Monday-Friday, 8:00am-4:30pm

Hiring Method: 6 month long contract with high likelihood for extension and/or permanent hire

Sick Time: Paid Holidays & 6 paid sick days annually

Benefits: Medical, Dental, Vision and 401K plans available


Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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