Analyst IV, Dossier Data Integrity, Quality Control Operations Job at R&D Partners, Cambridge, MA

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  • R&D Partners
  • Cambridge, MA

Job Description

Job Description

R&D Partners is seeking to hire an Analyst IV, Dossier Data Integrity, Quality Control Operations in Remote .

Your main responsibilities as an Analyst IV, Dossier Data Integrity, Quality Control Operations:

Verify the integrity and traceability of regulatory dossier sections.

Review regulatory dossier sections against associated reference methods and reports for accuracy in data reporting/transcription.

Review analytical data for accuracy in data reporting/transcription and for complete and correct entries of all associated references.

Verify the integrity and traceability of all data generated and reported.

Review data documented by laboratory personnel within laboratory notebooks, worksheets, logbooks (e.g., instrument use and maintenance logbooks) along with respective electronic data.

What we are looking for in a Analyst IV, Dossier Data Integrity, Quality Control Operations:

B.S. in chemistry, biology, or biochemistry, or related scientific field;

Pharmaceutical/Biotech industry experience with 5 years in a GMP Quality Control function or equivalent, relevant industry experience with demonstrated increase in responsibility

Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach

Demonstrated technical writing skills, with preference for technical writing of investigations

Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making

Why Choose R&D Partners ?

As an employee, you have access to a comprehensive benefits package including:

  • Medical insurance PPO, HMO & HSA
  • Dental & Vision insurance
  • 401k plan
  • Employee Assistance Program
  • Long-term disability
  • Weekly payroll
  • Expense reimbursement
  • Online timecard approval

Pay Scale:

$110,888 $138,611 ( Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

Job Requirements

Job Tags

Remote job,

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