Job Description:

Location: Holly Springs, NC

Salary: $60.00 USD Hourly - $70.00 USD Hourly

Description:



Quality Clinical System Manager




12+ Months




Holly Springs, NC




Hybrid role with up to 80% onsite support. Onsite schedule will be as needed.




Ideal candidate: Minimum of 12+ years of experience.




Three roles - the team is looking for three different specialties




1) Analytical validation & method




2) Both analytical validation & method experience and writing quality risk assessments (QRA's) for lab sample chain of custody.




3) Strong background in sample, stability, and reserve management. This person is going to assist in implementing the processes in place for the new site.




Ideally the candidate will have extensive diversified experience in commissioning of Quality Control (QC) Equipment supporting all QC laboratories, (Chemistry, Bioassay, Raw Material, and Microbiology). The candidate must have at least 15 years of functional experience and capable of leading technical documentation supporting Analytical Method Validation/Verification required to support GMP QC Laboratory readiness activities.




• Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.




• Core Analytical Competencies must include, but not limited to, HPLC/UPLC, HPIC, SEC (UV, CAD, ELSD, Fluorescence, Conductivity)K-F, TOC, ELISA, cell based assays, peptide mapping, glycan, aggregate and excipient analysis, and sample preparation techniques.




• Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup




• Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP)




• Manage document lifecycle updates to support QC Laboratory Readiness metric reporting




• Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications to support ANC QC Laboratory Readiness as necessary




• Provide validation and change management support for Laboratory Equipment/Method Readiness.




• Lead QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing




• Provide incident management support associated with nonconformances




• Identify technical/operational gaps and propose solutions.

Contact: tsultan@judge.com


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