Quality Control Specialist

This candidate will primarily be responsible for supporting late phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. This Quality team member will be responsible for initiating and assisting in investigations and troubleshooting while adhering to cGMP and GDP practices.

Responsibilities

• Actively participates in fostering a positive, collaborative work culture
• Authoring and revision of standard operating procedures, test methods, protocols, and reports
• Participate in execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations
• Testing of material utilizing methods such as FTIR, qPCR, Karl Fischer, Gel electrophoresis, bacterial enumeration, bacterial endotoxin, and bioburden
• Data analysis and review
• Initiate and participate in laboratory investigations including deviations and out of specifications
• Perform equipment calibrations and analysis of cell viability
• Execute method and equipment troubleshooting and optimization, as needed
• Maintain documentation in accordance with GDP

Qualifications

• B.S. degree in science or a life science-related field of study
• 7 + years of experience in Quality Control in GMP environment,
• Proficiency in culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)
• Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)
• Experience with writing standard operating procedures
• Familiarity with FDA, ICH, and EU Regulations and Guidelines
• Involvement in continuous improvement initiatives and laboratory investigations
• Proficiency in Microsoft Office suite applications
• Strong organizational and analytical skills; able to prioritize and manage through multiple complex processes/projects
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to work independently and stay on task in a fast-paced environment without direct supervision.
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
• Preferred experience in a microbiology laboratory
• Experience with the following instrumentation: FTIR, Electrophoresis, ELISA testing Preferred
• Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable