Senior Specialist 2, Quality Control Instrumentation
On-siteHolly Springs, North Carolina, United States
Job Summary
Manage the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation while ensuring data integrity and regulatory compliance. Develop and review SOPs, technical reports, user requirements, and KNEAT protocols; lead data integrity initiatives and periodic reviews of instrument control software. Partner with vendors to oversee maintenance activities and initiate follow-up on excursions and deviations, managing corrective and preventive actions. Collaborate with cross-functional partners including Validation, Labware Specialists, and Quality Assurance to ensure effective, compliant instrument operations. Includes periodic on-call and weekend support as needed.
Required Qualifications
- Bachelor's in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field
- Master's in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field
- PhD in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field
- 3+ years of experience in a GMP environment
- Prior hands-on experience with analytical instrumentation, including but not limited to UPLC/HPLC (Ultra/High-Performance Liquid Chromatography), Capillary Electrophoresis/Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis/Western Blot, Plate Readers, qPCR (Quantitative Polymerase Chain Reaction), Spectrophotometry, and Mass Spectrometry
- Experience qualifying analytical instruments
- Experience with Customer Relationship Management
- Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action [CAPA], document management system)
- Periodic on-call and weekend support, as needed
Desired Qualifications
- Master's in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience
- PhD in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience
- Bachelor's in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.