Quality Data Reviewer

CoreRx Inc - Clearwater, FL (30+ days ago)


General Description

ROLES & RESPONSIBILITIES:

  • Adherence to all company procedures
  • Auditing documentation including but not limited to batch records, reports, and certificates
  • Support of the document control systems.
  • Combining Lab Data with the appropriate Executed Batch Record
  • Review of Laboratory Data
  • Metrics - (errors by analyst, review category, batch record review etc.)
  • Submitting Supply Requests to Document Control
  • Metrology Review & Approve Calibrations
  • Equipment Change Control Approvals
  • Review and Approve Cleaning Verification/Validations
  • Review Process Validation
  • Approval of USP Water System Checks
  • Review/Approve/Reject Drug Product Specifications
  • Audit Preparation for Health Authority Inspections/Customer Audits as requested
  • Other tasks as needed

QUALIFICATIONS:

  • Fluency in written English
  • Proficiency in MS Office Applications; Outlook, Word, & Excel
  • Strong organizational skills
  • Proofreading skills
  • 30 word per minute typing minimum

Work Experience Requirements

  • 1-2 years quality department experience in a GMP regulated industry
  • 1-2 years in a pharmaceutical quality control laboratory
  • Experience with HPLC, spectrophotometers

Education Requirements

  • BS in chemistry or closely related discipline
  • MS in chemistry or closely related discipline may substitute for work experience

Job Type: Full-time

Experience:

  • quality department: 1 year (Required)

Education:

  • Bachelor's (Required)