Sr. Analyst, QC Analytical

Added
23 days ago
Type
Full time
Salary
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Related skills

lims hplc empower elisa uplc

πŸ“‹ Description

  • Lead analytical testing in cGMP QC labs using HPLC/UPLC/LCMS.
  • Provide mentorship and project management for QC Analytical activities.
  • Ensure data integrity and regulatory compliance (ICH/FDA/EMA).
  • Investigate OOS/OOT results with root-cause analysis.
  • Lead method lifecycle: development, transfer, and validation.
  • Collaborate with Manufacturing, QA, Regulatory, and Analytical Development.

🎯 Requirements

  • BS in Biochemistry or related pharma discipline.
  • 8+ years in a cGMP QC lab for a commercially approved product.
  • Hands-on experience with Empower, SoftMax, and LIMS.
  • Strong technical writing for SOPs, reports, and QC records.
  • Experience peer-reviewing QC data.
  • Experience with stability studies and data analysis.
  • Lean Six Sigma or process-improvement experience.

🎁 Benefits

  • Competitive base salary plus annual bonus.
  • Flexible PTO, holidays, and parental leave.
  • Generous health benefits, HSA match, and 401k match.
  • Employer-paid life and disability insurance.
  • Pet insurance and wellness discounts.
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