Clinical Systems Manager - Quality Risk Assessments

1 Year

Holly Springs, NC

Max PR: $71.60/hr

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

Ideal candidate: Minimum of 12+ years of experience.

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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 at the Company North Carolina facility.

• 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.

Basic Qualifications

• Doctorate Degree or Master Degree and 3 years of clinical experience or Bachelor Degree and 5 years of clinical experience or Associate degree and 10 years of clinical experience or high school diploma/GED and 12 years of clinical experience

Top 3 Must Have Skill Sets:

• Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.
• Experience leading QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing
• 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

Day to Day Responsibilities:

• Working with each QC Laboratory (Chemistry, Bioassay, Raw Material, and Microbiology), to create the technical documentation supporting Analytical Method Validation/Verification/Quality Risk Assessments/Equipment Commissioning required to support GMP QC Laboratory readiness activities at the Compnay North Carolina facility.

Job Details:

• Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical protocols/reports and business process documentation.
• When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process.
• May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Skills: ; MS Office expertise ; previous technical writing experience ; regulated environment experience ; document version control experience ; excellent communication/writing skills