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lims hplc empower elisa uplcπ 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.
π― 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.
π 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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