Senior Quality Control (QC) Operations Specialist

Piper Companies is seeking a Senior QC Operations Specialist in Durham, North Carolina (NC) , to join a rapidly growing biopharmaceutical organization. The QC Operations Specialist I will lead Contract Testing Laboratory (CTL) management, cross-functional communications, control chart implementation, batch release testing, and authorship of certificates and laboratory investigations. This role supports compliant testing, training, and audit readiness in a contract manufacturing facility producing monoclonal antibodies, recombinant proteins, and peptides.

Responsibilities of the Senior QC Operations Specialist :

• 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.
• Coordinate with CTLs to ensure timely results, review lab investigations / quality records.
• Author data summaries and certificates.
• Lead and review lab investigation and deviation reports.
• Implement control charts for new programs.
• Assist department in CAPA implementation and resolution.
• Ensure Trainer qualification status and identify training content.
• Revise SOPs and technical documents.
• Participate in inspection readiness activities.
• Track and improve department metrics, engage in continuous improvement projects.
• Maintain cGMP standards.

Qualifications of the Senior QC Operations Specialist I :

Compensation of the QC Operations Specialist I :