Senior Associate Quality Control Lead - Nights

Role Summary

Senior Associate Quality Control Lead - Nights responsible for leading the night shift QC operations in a GMP-regulated laboratory. Reports to the Director of Quality Control and provides independent technical execution and shift-level leadership to ensure accurate sample management, timely analytical testing, and ongoing compliance with GMP, data integrity, and safety requirements. This role partners with Manufacturing to support production schedules and drive continuous improvement while safeguarding laboratory standards.

Responsibilities

• Provide operational leadership for QC night shift activities, including sample receipt, prioritization, and accurate entry into LIMS.
• Serve as the primary QC point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation.
• Independently perform routine and complex 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.

Qualifications

• Required: High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience
• Required: Associate’s degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience
• Required: Bachelor’s degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience
• Required: Master’s degree
• Preferred: Prior experience serving as a shift lead, point of contact, or informal team lead within a QC laboratory.
• Preferred: Hands-on analytical testing experience in chemistry, bioassay, and/or microbiology.
• Preferred: Strong knowledge of data integrity, GDP, GMP, and 21 CFR Part 11 compliance.
• Preferred: Familiarity with compendial methods (e.g., USP–NF).
• Preferred: Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
• Preferred: High attention to detail, strong problem-solving skills, and ability to work autonomously during off-shift hours.