Senior Quality Control Analyst

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Role Overview:

• Responsibilities include Implementing, modifying, and enforcing Quality Control policies, procedures, specifications and testing methods consistent with cGMP, regulations, appropriate compendium, and company standards, policies, plans, objectives and procedures.
• Routine sampling, performing, and reviewing a variety of assays in the Quality Control organization in support of In-process, drug product, finished product, raw materials and incoming inspection, and environmental monitoring testing in a cGMP environment.
• The QC Analyst must be able to Interpret data, troubleshoots, assay failures and equipment issues while adhering to strict guidelines on cGMP documentation.
• Supports method validation activities, performance qualifications, method transfers, discrepancy/out-of-specification investigations and collaborates with stakeholders to identify improvement opportunities in technology and business processes.
• Ensure maintenance and calibration of laboratory equipment and systems.
• Support during cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures as required.

Duties:

• Impacts quality of own work and the work of others on the team; works within guidelines and policies.
• Maintain a state of inspection readiness.
• Works autonomously with guidance only on complex new assignments.
• Uses ability as a technical/functional expert to contribute in development of concepts and techniques, and to complete complex assignments in creative and effective ways.
• Perform environmental monitoring and water sampling.
• Has interaction at the Supervisor and Manager levels on matters pertaining to the immediate area of work. Interactions require tact and effective communication skills as they often involve complex and sensitive information.
• Participate in the design and implementation of department and cross-functional initiatives.
• Apply basic theory and technical principles to address moderately complex problems.
• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.

Requirements:

• B.A. or B.S. degree (preferably in Life Science) and at minimum 3 years experience in a cGMP pharmaceutical, biopharmaceutical industry
• Hands-on industrial laboratory experience with aseptic sampling and testing techniques.
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
• Routinely exercises sound judgment, reasoning and problem solving.
• Capable of working under moderate supervision and determining own short-term priorities.