Clinical Manager - Validation - Holly Springs Mississippi

Company: Collabera
Location: Holly Springs, Mississippi
Posted On: 01/17/2025

About the Role:

If the following job requirements and experience match your skills, please ensure you apply promptly.

We are looking for three different specialties to join our team.
The ideal candidates will have extensive experience in commissioning Quality Control (QC)
Equipment supporting all QC laboratories.

The roles include:

Analytical validation & method experience
Analytical validation & method experience and writing quality risk assessments (QRA's) for lab sample chain of custody
Strong background in sample, stability, and reserve management

Responsibilities:

Design and write protocols/reports for Method Validations, Verifications, Transfers, Material
Qualifications, and Stability studies
Develop Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures,
Equipment Data Integrity Assessments, etc.
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 and Compendial Verifications
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

Education Qualification:

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

Required Skills:

Extensive experience in commissioning Quality Control (QC) Equipment - Experience in
Analytical Method Validation/Verification
Proficiency in HPLC/UPLC, HPIC, SEC, K-F, TOC, ELISA, cell based assays, peptide mapping, glycan analysis, etc.
Strong technical writing skills
Experience in regulated environments
Document version control experience
Excellent communication skills If you have the required experience and skills More...

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