Overview
On Site
Full Time
Skills
Management
Auditing
Manufacturing
HPLC
ELISA
Corrective And Preventive Action
Training
Inspection
Continuous Improvement
Good Manufacturing Practice
Biochemistry
Analytical Skill
Testing
Critical Thinking
Writing
Quality Control
Health Care
Law
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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