Quality Control Analyst presso SBM Management Services

Description

As a Quality Control Analyst, you will play a pivotal role in our organization by championing quality assurance practices and driving excellence throughout our product development lifecycle. Through testing and analysis, you will conquer challenges, drive innovation and uphold regulatory compliance. You’ll work collaboratively with cross-functional teams to identify areas for improvement, drive process enhancements, and maintain adherence to regulatory requirements.

• Conduct thorough visual inspections of purchased materials (up to 60lbs), such as chemicals, buffers, or components used in laboratory and/or manufacturing operations, ensuring adherence to internal raw material specifications.
• Review supplier Certificates of Analysis (CofA) to assess compliance with internal specifications, evaluating the quality and suitability of the materials received.
• Review and approve assays and associated documents to authorize the release of materials, ensuring they meet the required quality standards.
• USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs.
• Perform aseptic sampling of raw materials and components, maintaining sterility and adhering to proper sampling techniques to ensure the integrity of the materials.
• Review, write, and revise internal documents such as Standard Operating Procedures (SOPs), Test Methods (TM), Raw Material Specifications (RMS), and forms, utilizing the Document Change Request (DCR) process to ensure accuracy and compliance.
• Foster effective communication and collaboration with external vendors/suppliers of raw materials and components, maintaining strong relationships and facilitating smooth interactions.
• Provide training and supervision to junior analysts, overseeing and guiding their experimental work to ensure accuracy and adherence to quality standards.
• Other tasks as assigned.

• Bachelor’s degree in chemistry/biology or equivalent industry experience.
• 2+ years of experience in a QC or analytical lab.
• Strong understanding of quality control principles, processes, and methodologies.
• Knowledge of relevant regulations and standards, such as Good Manufacturing Practices (GMP), ISO standards, or specific industry guidelines.
• Familiarity with analytical techniques and instrumentation commonly used in quality control.
• Experience with documentation and record-keeping in a regulated environment.
• Strong attention to detail, accuracy, and adherence to procedures.
• Excellent problem-solving and troubleshooting skills.
• Effective written and verbal communication skills.