Review commercial electronic batch records and documentation for completeness and accuracy in preparation for batch release
Correct and revise documentation as needed
Advise manufacturing personnel on proper documentation
Utilize knowledge of FDA and GMP regulations to ensure compliance
Conduct in Deviation/OOS investigations Qualifications for the Quality Assurance Specialist include:
A minimum of 1-5 years' experience within Pharmaceutical Manufacturing (sterile injectable is preferred)
Hands on experience with Batch Record review
Proficiency in Microsoft Office
B.S. in business or scientific field preferred Compensation for the Quality Assurance Specialist include:
Salary Range is dependent upon experience.
Comprehensive benefits package Keywords Quality Assurance Specialist, QA, Pharmaceutical, Branchburg, NJ, New Jersey, FDA, GMP, Batch Record, Manufacturing, GDP, cGMP, Sterile Injectable, Manufacturing, Regulatory Review, #

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