Associate Scientist (Quality)

About the Role

The Associate Quality Scientist provides technical and operational support to the Global Technical Quality Bioanalytical Team. In this role, you will support the Standards and Controls Program, perform routine enzyme assays, coordinate analytical materials and help maintain safe, compliant and efficient laboratory operations. The role is based in Wilmington, Delaware and requires on-site work.

Key Responsibilities

• Prepare, qualify, maintain, inventory and distribute enzyme standards and controls used in product testing and quality programs
• Perform routine enzyme assays and related bioanalytical testing using approved methods, procedures and established quality practices
• Prepare reagents, calibration standards, controls and samples, then accurately document, review and communicate test results
• Coordinate domestic and international shipments of standards, controls, samples, reagents, chemicals and laboratory supplies to manufacturing and testing sites
• Ensure analytical materials are properly packaged, labeled, documented, tracked and shipped in accordance with applicable safety and regulatory requirements
• Support investigations and troubleshooting related to assay performance, analytical variability and standards or controls issues under the guidance of senior scientists
• Maintain accurate records for standards, controls, test samples, shipments, inventory and laboratory activities
• Monitor inventory levels and coordinate the replenishment of critical reagents, reference materials, consumables and laboratory supplies
• Support data trending, Statistical Quality Control activities, method improvements, laboratory inspections, safety reviews, audits and other continuous improvement initiatives

Requirements & Tech Stack

• Bachelor’s degree in chemistry, biochemistry, biology, biotechnology, food science, microbiology or a related scientific discipline
• Basic understanding of laboratory safety, quality systems and Good Documentation Practices
• Ability to follow approved laboratory methods, procedures and work instructions accurately and consistently
• Strong attention to detail, organization and recordkeeping skills
• Effective written and verbal communication skills, with the ability to work collaboratively across scientific, quality and manufacturing teams
• Ability to manage multiple priorities and work effectively in an on-site laboratory environment
• Proficiency with Microsoft Office applications and the ability to learn laboratory data and inventory systems

Qualifications

• Previous laboratory experience in analytical testing, quality control, biotechnology or a bioanalytical environment
• Experience performing enzyme assays or preparing analytical standards, controls, reagents and samples
• Experience managing laboratory inventory or coordinating domestic and international shipments of analytical materials