What are the responsibilities and job description for the Senior Quality Control (QC) Operations Specialist position at Piper Companies?
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 :
Keywords : Quality Control, ELISA, STAT Samples, QC Operations Specialist, 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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