Data Reviewer

New Brunswick, NJ

Posted: 03/27/2023 Industry: Scientific Job Number: 23-00126

Job Description

The Data Reviewer for the Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.
  • Ensures compliance with cGMP/cGLP and good documentation procedure during the review process
  • Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist
  • Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses
  • Informs the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity
  • Reports all audit finding in the ODR audit worksheets and highlight noteworthy/ major/ critical observations on CDRO certifications
  • Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system
  • Collates audit findings in the audit comments log
  • Performs any other responsibilities which are required as assigned by the manager/s depending on departmental needs
  • Completes all training requirements as per Learning Management System (LMS) and as per Safety
  • Adheres to the Safety and Health Program and associated plans.

Corporate office environment
Laboratory environment QC and ARD
Manufacturing / Production environment
The ODR data reviewer will be mainly working in an office environment as the job requires review of copies of reference documents. Exposure to laboratory/ manufacturing environments is at a minimum only and only expected when the ODR data reviewer needs to physically view any concerns or needs to have a face-to-face discussion with the stakeholders.

Education and Experience:
  • Minimum Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field. A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is desirable.
  • Knowledge in and review of, but not limited to, the following: Laboratory test procedures, cGMP/cGLP/cGDP requirements, ICH/US FDA guidelines, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures; standard operating procedures, general procedures, test procedures, validation protocols; manufacturing and packaging batch records, excipients COAs, packaging components COAs, manufacturing reports, scale-up reports, product development reports; Quality overall summaries, executive summaries
  • Proficient in MS Office applications (Word, Excel)
  • Ability to monitor, coordinate and prioritize work in an effective and efficient manner, with capacity to manage simultaneous projects within a set timeline; ability to continuously make an assessment of the work load and suggest any support required on need basis
  • Must be a self-motivated, proactive team player with positive interaction with colleagues and stakeholders to ensure work ethics, teamwork, and discipline.
  • Conduct oneself in a professional manner in alignment with corporate values.
  • Ability to work and interact successfully in a global, diverse and dynamic environment.
  • Demonstrates excellent interpersonal communication skills: verbal, written and presentation skills.
  • Excellent project management and problem solving skills
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
  • Minimum 5 years of experience in a pharmaceutical company within a cGMP environment in
  • Quality Control and/or Analytical R&D department is required.
  • Minimum 2 years of Quality Assurance exposure in Pharmaceutical industry, involving review of manufacturing/ packaging batch records and investigations is desirable

Meet Your Recruiter

Felice Santiago

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