Senior QC Analyst I - LIMS, Samples & Batch Disposition

ClinLab Solutions Group; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

ClinLab Solutions Group in Durham, NC seeks an experienced Quality Control Operations professional to support critical QC workstreams, including sample management, LIMS/LES management, and batch disposition. This on-site role reports to the Senior Manager of Quality Control Operations.

The ideal candidate will have a Bachelor’s degree in a scientific field, 5 years in pharma/biotech, and strong skills in QC processes, LIMS, data reconciliation, and cross-functional collaboration.

Qualifications

• Minimum Bachelor’s degree in a scientific discipline.
• 5 years’ pharmaceutical/biotech experience with drug substance/product manufacture, development or quality.
• Knowledge of QC workflows, sample management, and testing.
• Experience with LIMS or equivalent system.
• Excellent communication, detail orientation, and cross-functional change leadership.
• Strong team player with customer service mindset and solution orientation.
• Attention to detail and ability to work both independently and in multi-disciplinary teams.
• Proven leadership and vendor management skills.
• Strong listening and interpersonal skills to foster team spirit.
• Consistent delivery of high-quality work.

Responsibilities

• Sample management including QC samples, reference samples, retain samples, and stability samples.
• Implementation and maintenance of LIMS and LES systems.
• Oversight of contract laboratory data collection including sample submission, data review, and result reconciliation.
• Batch disposition including analytical reports and certificates.
• Quality events including investigational writing and executing change controls.

Skills

QC processes knowledge

LIMS experience

Communication skills

Detail-oriented

Leadership skills

Vendor management

Education

Bachelor’s degree in a scientific discipline

Tools

LIMS

LES systems

Job description

ClinLab Solutions Group in Durham, NC seeks an experienced Quality Control Operations professional to support critical QC workstreams, including sample management, LIMS/LES management, and batch disposition. This on-site role reports to the Senior Manager of Quality Control Operations.

The ideal candidate will have a Bachelor’s degree in a scientific field, 5 years in pharma/biotech, and strong skills in QC processes, LIMS, data reconciliation, and cross-functional collaboration.