Senior Lab Data Reviewer

4 weeks ago

Philadelphia, United States Adare Pharma Solutions Full time
Job DescriptionJob Description

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery

Join our mission at Adare

What can Adare offer you?

  • Medical/dental/vision/life – low employee premiums
  • 401k with a highly competitive match
  • Generous PTO, including floating holidays
  • Career growth and internal opportunities
  • Tuition reimbursement
  • Relocation assistance
  • Performance-based bonus
  • Employee Recognition Programs


We are seeking to hire a Senior Lab Data Reviewer to join our Analytical Research and Development team…

If any of the below describes you, we would love to meet you

Summary

The Senior Lab Data Reviewer is a key member of Adare’s Analytical Research and Development team, and will be responsible to thoroughly audit all cGMP analytical work performed by the Analytical R&D. Additionally, the Senior Lab Data Reviewer is expected to carefully verify compliance with cGMP, assist in lab investigations, conduct internal auditing, and play a critical role in continuous improvements.

Responsibilities and Learning Opportunities

  • Responsible to thoroughly check all cGMP analytical work in ARD for completeness and accuracy in terms of calculation, technicality, compliance, SOP, cGMP and adherence to analytical methods and protocols.
  • Responsible to rectify improper data and document as required.
  • Reports discrepancies to Supervisor/Manager/Analyst and follow up with analysts for document corrections.
  • Assist with lab investigations and reports.
  • Conduct internal auditing.
  • Collect and summarize auditing finding
  • Play a critical role in continuous improvements of quality
  • Attend SOP, Safety and scientific trainings to remain current with cGMP regulations, and safety standards
  • Follow relevant Adare SOP’s and FDA/ICH guidance
  • Other duties as assigned

Requirements

  • BS or higher degree in Chemistry or related major with 10 years of experience working in GMP environment in pharmaceutical analytical labs
  • Good understanding of chemical and physical analysis principles, knowledge and experience in chromatography analysis, UV, IR, and dissolution.
  • Good understanding of GMP, ICH and FDA compliance
  • Good understanding and 5 years of hands-on experience with Empower
  • Experiences in both Analytical R&D lab and Quality Control lab is preferred.
  • Good written and oral communication skills and interpersonal skills
  • Good computer skills

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES

Benefits

  • Medical/dental/vision/life – low employee premiums
  • 401k with a highly competitive match
  • Generous PTO, including floating holidays
  • Career growth and internal opportunities
  • Tuition reimbursement
  • Relocation assistance
  • Performance-based bonus
  • Employee Recognition Programs

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