Covance

QC Reviewer

CN-31-Shanghai
Job Number
2017-14987
Job Category
Scientific Bachelor's Degree
Position Type
Full-Time

Job Overview

 

We are expanding our Early Development (ED), Bio Analysis (Large Molecule) Group and looking for talented QC Reviewer with solid experience in GLP regulation. 

 

Essential Job Duties:

  • Reviews study documentation and laboratory records.
  • Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
  • Informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data and recommends corrective actions.
  • Participates in process improvement initiatives. Provide suggestions for changes in experimental process to improve efficiency of daily/routine procedures and compliance with regulatory agency guidelines, as applicable.
  • Assure technical staff compliance to SOPs and other regulatory agency guidelines
  • Performs QC review of data.
  • Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
  • Responsible for reviewing and monitoring process of experiments, including documentation, SOP and/or regulatory guidelines compliance.
  • Assists in interpreting and evaluating data for incorporation into written reports.
  • Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
  • Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
  • Prepares for and participates in routine client visits.
  • Manages data transfer to clients as requested.
  • Assists SD/PI in monitoring study phases.
  • Assists with training and mentoring less experienced staff.
  • Assists in writing SOPs
  • Maintains an awareness of the financial status of ongoing studies.
  • Performs other related duties as assigned

Education / Qualifications*

  • BS/BA degree in science plus at least 4-5 years experience or MS degree with 2-4 years experience.

Experience* 

  • Efficient use of word processing software, database, spreadsheet, and specialized software.
  • Proficient in concise writing. Writing should require little or no external review or edit.
  • Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
  • Experience on a variety of studies performed in the department and exposure to a diverse client base.
  • Knowledge of regulatory agency guidelines.

We Offer

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.  At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

There is no better time to join us!

Education/Qualifications

  • BS/BA degree in science plus at least 4-5 years experience or MS degree with 2-4 years experience.

Experience

  • Efficient use of word processing software, database, spreadsheet, and specialized software.
  • Proficient in concise writing. Writing should require little or no external review or edit.
  • Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
  • Experience on a variety of studies performed in the department and exposure to a diverse client base.
  • Knowledge of regulatory agency guidelines.

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