Senior Associate Quality Control - Nights

• Execute QC night shift activities, working with the night shift team lead, including sample receipt, prioritization, and accurate entry into LIMS
• Serve as a point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation
• Independently perform routine and sophisticated analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required
• Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements
• Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership
• Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS)
• Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives

• High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience
• Associate’s degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience
• Bachelor’s degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience
• Master’s degree
• Experience working in a GMP-regulated Quality Control laboratory with proven ability to work independently

• Prior experience with hands-on analytical testing experience in chemistry, bioassay, and/or microbiology
• Solid understanding of data integrity, GDP, GMP, and 21 CFR Part 11 compliance
• Familiarity with compendial methods (e.g., USP–NF)
• Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment
• High attention to detail, strong problem-solving skills, and ability to work autonomously during off-shift hours

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards