Senior Quality Data Reviewer

2 weeks ago


Clearwater, United States The Staffing Resource Group Inc Full time
Job Description

Senior Quality Data Reviewer
  • Title: Senior Quality Data Reviewer
  • Location: Clearwater, FL
  • Industry: Pharmaceutical (GMP environment)
  • Pay Rate: $25 an hr.
  • Employment Type: 2-month contract (Covering someone on medical leave)
Client Overview
A dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. This company is a contractor development manufacturing organization environment that is fast-paced and mainly focuses on oral solid dosage.

Position Overview:
The Senior Data Reviewer is responsible for the systems and personnel that oversee the generation of data supporting the client s products. This includes review of laboratory data, equipment records, facility records and manufacturing batch records.

Responsibilities:
  • Workflow management with multiple reviewers.
  • Team leadership of the data review team.
  • Approval of analytical method and equipment validation reports.
  • Perform final release of product.
  • Approval of Certificates of Analysis
  • Ensuring data integrity across the company systems
  • Adherence to all company procedures
  • Auditing documentation including but not limited to batch records, reports, and certificates
  • Performing and participating in audits, cycle audits, vendor audits.
  • Support of the document control systems.
  • Reply to client s questions and inquiries concerning batch record review
  • Combining Lab Data with the appropriate Executed Batch Record
  • Review of Laboratory Data
  • Metrics - (errors by analyst, review category, batch record review etc, provide to specialist)
  • Review OOS Investigations
  • 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:
  • BS in chemistry or closely related discipline
  • MS in chemistry or closely related discipline may substitute for work experience
  • 5+ years quality department experience in a GMP regulated industry
  • 1-2 years in a pharmaceutical quality control laboratory
  • Experience with HPLC, spectrophotometers and other laboratory equipment
  • Fluency in written English
  • Proficiency in MS Office Applications; Outlook, Word, & Excel
  • Strong organizational skills
  • Proofreading skills
  • 30 words per minute typing minimum

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the federal contracting industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

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