Sr QC Analyst I

Work Location: Durham County, North Carolina

Summary:

The Sr QC Analyst I is responsible for supporting essential quality control activities related to manufacturing, including sample management, system implementation, and batch disposition. This role requires daily on-site engagement and collaboration with cross-functional teams to ensure quality standards are met.

Responsibilities:

• Manage various types of samples, including QC, reference, retain, and stability samples, ensuring proper documentation and storage.
• Implement and maintain laboratory information management systems (LIMS) and laboratory execution systems (LES) to support QC operations.
• Coordinate and oversee contract laboratory data collection, including sample submission, data review, and reconciliation of results.
• Support batch disposition processes by preparing and reviewing analytical reports and certificates.
• Participate in quality events, including writing investigations and executing change controls as needed.
• Collaborate with internal and external partners to drive process improvements and ensure compliance with quality standards.
• Provide guidance and support to team members, fostering a collaborative and solution-oriented work environment.
• Ensure consistent delivery of high-quality work while managing multiple priorities and maintaining attention to detail.

Qualifications:

• Bachelor’s degree in a scientific discipline.
• 5 years of experience in the pharmaceutical or biotech industry, with a focus on drug substance/drug product manufacturing, development, or quality.
• Knowledge of quality control business processes, including sample workflow and testing procedures.
• Experience with LIMS or equivalent qualified software systems.
• Excellent verbal and written communication skills, with a detail-oriented and proactive approach.
• Strong team player with a customer service mindset and a solution-oriented attitude.
• Ability to work independently, within multidisciplinary teams, and with external partners and vendors.
• Demonstrated team building, leadership, and management skills.
• Outstanding listening, communication, and interpersonal skills to foster team spirit.
• Consistent track record of delivering high-quality work.
• Proven ability to manage vendors and stakeholders involved in quality and regulatory activities to achieve objectives.

Published Category: Quality & Validation