What are the responsibilities and job description for the Senior Quality Control (QC) Operations Specialist position at Zachary Piper Solutions, LLC?
Job Details
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:
Qualifications of the Senior QC Operations Specialist I:
Compensation of the QC Operations Specialist I:
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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