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Job Details

ID #15405283
State New York
City Orangetown
Job type Contract
Salary USD $28 - $33 per hour 28 - 33 per hour
Source Real Staffing
Showed 2021-06-13
Date 2021-06-13
Deadline 2021-08-12
Category Et cetera
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Data Reviewer

New York, Orangetown, 10913 Orangetown USA

Vacancy expired!

The purpose of this position is to review all analytical data (raw and electronic) and support 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.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

This position is responsible for performing the review of all analytical reports and raw and electronic data from NY Quality Control (QC) including raw materials, finished products, stability study samples, packaging materials, in-process materials, cleaning analysis, and/or equipment calibration and informing the QC Manager when tests are not within specified limits to take appropriate actions. Other key accountabilities specific to the function include:

  • 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 including all tests according to the in-house monographs and USP in a regulated laboratory environment.
  • 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.
  • Performs other duties and projects as assigned by management.

PERFORMANCE MEASUREMENTS

  • On time review of analytical data resulting in few or no delays in product release
  • First Time Right data review resulting in no nonconformities

    • Benefits:

    • Health insurance
    • Casual Dress code
    • 401k match

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    EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    Vacancy expired!

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