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:

• B.S. degree with 6 years of related experience, M.S. degree with 4 years of related experience, or Ph.D. in a related scientific discipline with 1 years of relevant experience.
• Strong biochemistry background in biopharmaceutical analytical testing.
• Excellent critical thinking and troubleshooting skills.
• Ability to analyze, interpret, and present complex data.
• Excellent writing skills with a full grasp of grammar, spelling, and style rules.

Compensation of the QC Operations Specialist I:

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

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