Senior Lab Analyst

<h1><b>Use Your Power for Purpose</b></h1><p>Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.</p><p></p><h2><b>What You Will Achieve</b></h2><p>In this role, you will:</p><ul><li><p>Assist in the preparation and maintenance of media stocks, including sterilization of accessories by autoclave cycles.</p></li><li><p>Manage receipt, storage, and handling of Bio ball cultures, and assist in the maintenance of Master cultures and preparation of Cryo vials.</p></li><li><p>Perform various microbiological tests such as water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test, CCIT, and micro challenge studies.</p></li><li><p>Ensure training records are updated and correctly filed to reflect current testing capabilities.</p></li><li><p>Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.</p></li><li><p>Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.</p></li><li><p>Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.</p></li><li><p>Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.</p></li><li><p>Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database, and generate EMS reports.</p></li><li><p>Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.</p></li></ul><p></p><h2><b>Here Is What You Need (Minimum Requirements)</b></h2><ul><li><p>Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience</p></li><li><p>Demonstrated technical skills in method validation and testing</p></li><li><p>Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations</p></li><li><p>Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.</p></li><li><p>Excellent organizational skills and strong ability to multi-task</p></li><li><p>Strong written and verbal communication skills</p></li><li><p>Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation</p></li></ul><p></p><h2><b>Bonus Points If You Have (Preferred Requirements)</b></h2><ul><li><p>Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography) techniques</p></li><li><p>Proven track record in leading continuous improvement projects</p></li><li><p>Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis</p></li><li><p>Strong problem-solving skills and attention to detail</p></li><li><p>Ability to manage multiple priorities and meet deadlines.</p></li><li><p>Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels</p></li><li><p>Adaptability and willingness to learn new techniques and procedures</p></li><li><p>Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use</p></li></ul><p>  <br/> </p><p><b>PHYSICAL/MENTAL REQUIREMENTS</b></p><ul><li><p>Considerable concentration and some manual dexterity.</p></li><li><p>Long periods of standing and sitting and significant walking.</p></li><li><p>Regular lifting (less than 35 lbs.) and reaching may be required to retrieve chemicals, reagents, and samples.</p></li><li><p>Extended time working at a computer</p></li><li><p>Maintains a clean and organized laboratory environment.</p></li><li><p>Strict documentation requirements.</p></li><li><p>Cooperates with other colleagues, departments, and sites.</p></li></ul><p></p><p><b>NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS </b></p><ul><li><p>May require off-shift and week