Senior QC Analyst (2Nd Shift)

Piper Companies is seeking a Senior QC Analyst (2nd Shift) - In-Process in Durham, North Carolina (NC), to join a rapidly growing biopharmaceutical organization. The Senior QC Analyst (2nd Shift) will be trained to execute analytical test methods and corresponding analytical techniques, supporting QC testing for in-process, characterization, release, or stability samples. Additionally, they will assist with troubleshooting and support In-process Support Associates with STAT samples during the 2nd shift.

Responsibilities of the Senior QC Analyst (2nd Shift):

• Perform in-process, characterization, stability, and release testing as assigned, including HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance.
• Execute method transfer, method qualification, and method validation testing performed under protocol.
• Prepare solutions and organize/process samples according to GxP standards.
• Conduct independent analysis and collation of data to draw conclusions.
• Enter data into control charts and LIMS, if applicable.
• Support lab investigations and deviation reports.
• Support implementation of Corrective and Preventive Actions.
• Revise SOPs and technical documents.
• Troubleshoot testing or project challenges and present data.
• Track department metrics and actively engage in improvement.
• Participate in continuous improvement projects or lead simple improvement projects.
• Ensure safety and regulatory audit readiness at all times.
• Maintain work to current Good Manufacturing Practices (cGMP).
• Ensure Trainer qualification status to expand team matrix.
• Provide laboratory support - ensure areas are neat, clean, organized, and equipment is functioning.
• Participate in data review activities.
• Support STAT testing coordination.
• Required to be onsite full time with a minimum of 75% of time in the laboratory/facility.

Qualifications of the Senior QC Analyst (2nd Shift):

• BS in a scientific discipline with relevant experience in QC testing, method transfer, and validation.
• Bachelor's degree as described and 4+ years' experience or Master's Degree with 2+ years experience.
• Expertise in analytical methods such as HPLC, ELISA, qPCR, and SoloVPE.
• Strong understanding of cGMP standards and regulatory compliance.
• Excellent communication and problem-solving skills.

Compensation of the Senior QC Analyst (2nd Shift):

• Competitive salary based on level of experience.
• Comprehensive benefits package: Healthcare, Dental, Vision, 401K, and sick leave as required by law.

Keywords: Quality Control, ELISA, STAT Samples, Senior QC Analyst, In-Process Testing, 2nd Shift, Analytical Test Methods, HPLC, qPCR, SoloVPE, Spectrophotometric Techniques, Capillary Electrophoresis, Compendial Testing, Method Transfer, Method Qualification, Method Validation, GxP Standards, Data Analysis, Control Charts, LIMS, Lab Investigations, Deviation Reports, Corrective and Preventive Actions (CAPA), SOP Revision, cGMP Compliance, Continuous Improvement, Biotechnology, Pharmaceutical Manufacturing

This job opens for applications on 1/10. Applications for this job will be accepted for at least 30 days from the posting date."

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