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Senior QC Analyst - In Process

Piper Companies
Piper Companies Salary
Durham, NC Full Time
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/8/2025

Piper Companies is searching for a dedicated and experienced Senior QC Analyst to join the Quality Control team of a growing biotechnology company focused on accelerating the development of innovative biological products and expanding global access to medicines. The Senior QC Analyst will be responsible for executing analytical test methods and techniques, focusing on QC testing for in-process, characterization, release, or stability samples.

This is an on-site 2 nd Shift role, Monday through Friday, 2 PM – 10 : 30 PM (EST) in Durham, NC.

Responsibilities of the Senior QC Analyst :

  • Perform in-process, characterization, stability, and / or release testing using techniques such as HPLC, ELISA, qPCR, SoloVPE, spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP
  • Execute method transfer, qualification, and validation testing under protocol
  • Prepare solutions and organize / process samples according to GxP standards
  • Support lab investigations, deviation reports, and implementation of Corrective and Preventive Actions
  • Troubleshoot testing or project challenges and present data effectively
  • Participate in continuous improvement projects and ensure safety and regulatory audit readiness

Qualifications of the Senior QC Analyst :

  • Bachelor’s degree with 4 years of experience or Master’s degree with 2 years of experience in a related field
  • Experience performing testing on in-process and drug substance samples using bio-analytical techniques and strong understanding of the biologics production process
  • ELISA experience preferred and a plus
  • Hands-on experience with execution of method transfer, method qualification, and / or method validation testing
  • Ability to read, understand, and follow analytical test methods (ATMs) and standard operating procedures (SOPs)
  • Compensation for the Senior QC Analyst :

  • Salary Range : $40 / hr - $50 / hr based on experience
  • Comprehensive Benefits including Medical, Dental, Vision, 401k, PTO, Sick Leave if required by law, & Holidays
  • This job opens for applications on 1 / 7 / 2025. Applications for this job will be accepted for at least 30 days from the posting date.

    Keywords : QC, Deviation, Investigation, Biologic, Biologic Production, Biotechnology, Quality Control, Good Manufacturing Practices, GMP, Standard Operating Procedures, SOP, Analytical Testing, Environmental Monitoring, Microbiology, Bioburden Testing, Endotoxin Testing, Data Analysis, Laboratory Equipment Maintenance, Compliance, Regulatory Standards, Quality Assurance, QA, Validation, Documentation, Troubleshooting, Aseptic Techniques, Chromatography, HPLC, GC, Spectroscopy, UV / Vis, IR, Laboratory Information Management System, LIMS, Durham, RTP, Raleigh, North Carolina

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    Salary : $40 - $50

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