Quality Control Associate


Job ID 18-00014

Industry Pharma

Job Type Contract

Location Cranbury, NJ

Description

POSITION SUMMARY
The QC Associate Contractor will review and compare clinical, regulatory submission documents, clinical study reports, protocols, versus source documents for accuracy, content, formatting and compliance to local guidance's. Examples of source documents are as follows: statistical tables/listings/figures, clinical study reports, statistical analysis plans, references, company style guide and local regulatory guidance's. In addition, the associate may interact with vendors regarding Trial Master Files (TMFs) or in relation to any other services the vendor is providing.

ROLES AND RESPONSIBILITIES

  • Understanding statistical data-listings, tables and figures to ensure they are incorporated and interpreted appropriately into the written document.
  • Verifying source data to written document in clinical study reports and regulatory submission documents.
  • Assisting in the resolution of comments from Quality Assurance.
  • Cross functional interactions include medical writing, QA, regulatory, Pharmacovigilance, statistics and clinical teams.

 

TRAVEL

  • 0-5%


Qualifications

REQUIREMENTS

  • BS Degree, or equivalent experience plus a minimum of 3 years' industry experience in a QC role.
  • The ideal applicant would have GCP training, particularly in areas such as data reporting and clinical trial management, as well as experience in written communication.
  • A good understanding of GCP, study Table, Listings and Figures, eCTD (Common Technical Document) and clinical operations procedures.
  • A minimum of 3 years' of QC experience for a pharmaceutical company is preferred.
  • The applicant would have previous experience in reviewing statistically generated Tables, Listings and Figures, reviewed clinical study reports and submission documents.

EXPERIENCE AND SKILLS

  • This position requires computer skills, such as Word, Excel and Power Point.
  • Applicant must be able to communicate well with cross functional areas such as medical writing, regulatory, data management and statistics.
  • This individual will also support the clinical operations functions in responding to Quality Control Audits, Regulatory Inspections.
  • The applicant must be able to communicate with other functional groups on the documents needed, such as source documents, in order to perform a 100% QC.