QA Compliance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
Boston, USA
Posting date: 11 Aug 2020

Proclinical is currently recruiting for a QA Compliance Specialist with a biotechnology company located in Boston, MA.

Job Responsibilities:

  • Compile data and develop analysis to support Quality Management Reviews (QMR)
  • Assist in administering Global Quality analytics processes and developing statistical analysis and reporting mechanisms for GXP systems and processes.
  • Assist in conducting & establishing trending analysis
  • Participate in process for requesting, reviewing and approving new and/or revised metrics and programs.
  • Provide input and support managing Quality system analysis.
  • Assist in implementing and maintaining processes aligned with applicable policies and standards to report on QS performance data

Skills and Requirements:

  • 4 to 6 years of experience in biopharmaceutical/pharmaceutical or related industry with background in statistics
  • Experience participating in cross-functional projects
  • Knowledge of cGMPs, GXPs and Quality Systems required
  • Experience developing monthly/quarterly management reports
  • Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.)
  • Experience with statistical analysis
  • Strong Excel and PowerPoint background
  • Experience with quality management systems such as TrackWise, training management system, and document management system preferred.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.