The Associate Scientist II, Quality Control supports and independently executes quality control activities for microbiological, next generation sequencing, biologics, and related products. The role applies established technical knowledge to perform and troubleshoot routine and moderately complex laboratory workflows, analyze and communicate results, support investigations and process improvements, and maintain compliance with the quality management system. This position works closely with Manufacturing, Process Development, Quality Assurance, and operational partners.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties: 

• Independently execute routine and moderately complex QC testing and operational workflows to support production schedules, product release, development activities, and customer requirements

• Identify assay, documentation, and process improvement opportunities through first-hand observation and data review; implement approved improvements and contribute technical input to change activities

• Perform primarily tactical laboratory work with responsibility for planning assigned daily activities, prioritizing work, and completing defined technical assignments with limited day-to-day direction

• Collaborate with local QC, Manufacturing, Process Development, Quality Assurance, and Operations partners; provide reliable technical information to support cross-functional work

• Document laboratory activities and quality records clearly; summarize results, observations, risks, and recommended next steps to technical staff, peers, and leadership

• Provide task-level guidance, peer support, and on-the-job training to less experienced team members when assigned

• Own assigned workflows, test methods, equipment, or product-family activities within established procedures; support scheduling, readiness, documentation, and issue resolution

• Apply working knowledge of microbiology, molecular biology, analytical methods, aseptic technique, and standard laboratory equipment; serve as a developing technical resource in assigned areas

• Participate in and independently complete defined improvement projects, lean initiatives, investigations, and corrective or preventive action activities

• Process, review, trend, and interpret test data using approved methods and good documentation practices; contribute to reporting of quality, productivity, right-first-time, and other relevant performance indicators

• Perform laboratory and light manufacturing activities requiring repetitive hand movement, close visual work, standing, walking, and handling materials in accordance with the physical requirements below

• Perform work in accordance with approved SOPs, work instructions, applicable regulatory requirements, ISO 13485 quality system requirements, safety expectations, and PPE policies

• Perform other duties as required or assigned by management to meet business needs