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Pharmaceutical QC Data Reporting Analyst

Company: Eurofins Lancaster Laboratories
Location: Cropseyville
Posted on: January 16, 2022

Job Description:

Job Description

  • Ability to work independently and as part of a team in a fast-paced, client facing environment.
  • Self-motivated, adaptable, and a positive attitude
  • Excellent communication (oral and written) and attention to detail
  • Compile internally and externally generated data in support of compiling CofAs and SofAs.
  • Prepare and provide CofAs and SofAs for all lot release materials
  • Work with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.
  • Trend QC product release data to support lot release and regulatory filings
  • Provide trending analyses to support various activities such as manufacturing investigations, and validation studies.
  • Assist in the implementation and maintenance of product release and stability data trending program for each product candidate
  • Prepare product annual release and stability data trending reports
  • Prepare monthly release data trending reports or as required
  • Perform reference standard trending
  • Perform trending of relevant systems suitability parameters
  • Prepare stability trend reports
  • Prepare and populate matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
  • Compile data to support QC department metrics and performance tracking
  • Assist with the improvement effort of streamlining the review and release process
  • Ensures compliance with applicable cGMP regulations and SOPs
  • Meet specified timelines to support release and regulatory filings
  • Complies with all pertinent regulatory agency requirements.
  • Participates in required training activities.

    • BS/BA in Chemistry, Biochemistry or related field and some relevant work experience
    • Have a basic understanding of Microsoft Suite (Word, Excel, PowerPoint)
    • 1+ years of experience working in a cGMP pharmaceutical environment
    • Quality Control Laboratory experience is preferred but not required.
    • Must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm. Develop and drive scientific and/or business-related improvement ideas

      Additional Information

      Position is full-time, 1st shift, Monday-Friday. Candidates currently living within a commutable distance of Rensselaer, NY and the surrounding areas are encouraged to apply.
      • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
      • Life and disability insurance
      • 401(k) with company match
      • Paid vacation and holidays

        Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

        Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins Lancaster Laboratories, Albany , Pharmaceutical QC Data Reporting Analyst, Advertising , Cropseyville, New York

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