Senior QC Analyst

The incumbent will support the implementation and execution of critical QC work streams in support of manufacturing. These work streams 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.

• 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

• 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.