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Data Reviewer

Les Services Kelly

This is a Full-time position in Montréal, QC posted September 4, 2018.

Job Title: Data Reviewer

Type of position: Permanent, Full time

Location: Saint-Laurent, Montréal

Kelly Services is a global leader in providing workforce solutions and a Fortune 500 Company. Serving and consulting clients in Pharmaceutical, Biotech, Medical Device, Diagnostics, Health and other manufacturing sectors. Kelly offers employment to more than 530,000 employees annually. Kelly’s success is driven by our commitment to quality, innovation and to provide the world’s best workforce solutions.

Kelly Scientific is currently looking for a Data Reviewer to join the team of our client in Montreal. As part of this position, you will be responsible for the following tasks:

Responsibilities:

  • Perform detailed data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications to support production, stability studies and lab operation.
  • Review release and stability data, trend charts of reference standards, lab equipment calibration records and log-books and other review function as needed.
  • Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy.
  • Interact with lab analyst and other peer groups to support analytical and stability report writing and regulatory updates.

Key Requirements:

  • Requires BS in Chemistry or closely related field.
  • A minimum of 3+ years’ relevant experience, preferably in cGMP pharmaceutical environment, is required.
  • Prior experience as a laboratory analyst.
  • Experience and familiarity with analytical testing equipment, software and methodology including HPLC, dissolution, Spectrophotometry (UV/VIS), GC, IC and other physical testing techniques.
  • Familiarity with ICH and CFR guidance’s.Ability to gather, generate, and interpret data.
  • Excellent organizational and interpersonal skills and ability to communicate with transparency.

Skills Required

  • Education level: None
  • Work experience (years): None

Package

Salary: N/D


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