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Pharmaceutical QC Data Reporting Analyst

2 months ago


Rensselaer, United States Eurofins USA PSS Insourcing Solutions Full time

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.

Qualifications:
Qualifications

  • 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 preferred
  • 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 8am-4:30pm. Candidates currently living within a commutable distance of Rensselaer, NY and the surrounding areas are encouraged to apply. Pay is between $24-28/hr and level is determined on experience.

  • 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.