Data Reviewer

2 days ago


Orangeburg, South Carolina, United States PDI Full time

PDI is seeking a highly skilled Data Reviewer to join our team. As a Data Reviewer, you will be responsible for reviewing all analytical data (raw and electronic) and supporting the release of raw materials, bulk liquids, and/or finished goods.

This position also performs data review of stability studies, R&D studies, cleaning studies, and any other data, as needed.

Key Responsibilities:

  • Review and approve all tests results, including raw data and electronic data generated in support of testing of raw materials, in-process, finished product and/or stability samples.
  • Review all validation and method optimization reports.
  • Review all laboratory notebooks for correctness of raw data and verify all reagents, standards and equipment used are within the acceptable range.
  • Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
  • Ensure all testing/analysis is conducted according to approved test methods, standard operating procedures and/or associated documents and meets the product specific requirements.
  • Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
  • Support QC and QA managements during regulatory, customer, corporate, and internal audits.
  • Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
  • Analyze and interpret results in written and oral format.
  • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.

Requirements:

  • Bachelor's degree in Chemistry or related field.
  • 4+ years related experience in pharmaceutical analysis.
  • cGMP/regulatory and data integrity experience is preferred.

Benefits:

  • Comprehensive and affordable benefits for our associates, including medical, dental, vision, 401(k) savings plan with company match and profit sharing, and more.

About PDI:

PDI is a leading provider of innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness.


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