Senior QC Analyst I

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

The incumbent will support the implementation and execution of critical QC workstreams in support of manufacturing. These workstreams include sample management, LIMS and LES management, and batch disposition. This role requires daily on-site presence and engagement. The position will report to the Senior Manager of Quality Control Operations.

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

Qualifications

• Bachelor’s degree in a scientific discipline.
• 5 years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
• Knowledge of QC business processes, inclusive of sample workflow and testing.
• Experience with LIMS or equivalent qualified software system.
• Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent team building, leadership and management skills.
• Excellent listening, communication and interpersonal skills, fostering team spirit.
• Consistent delivery of high-quality work.
• Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.