Clinical Systems Manager

Payrate: $ 60.50 to $ 63.16/hr

Summary:

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 North Carolina facility.

Job Responsibilities:

• 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.
• 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.
  
  

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
  
  

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.

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