Manager Quality Control I - Night Shift

Role Summary

Manager Quality Control I (Night Shift) leads night-shift QC operations in a GMP-regulated laboratory. The role provides independent technical execution and shift-level leadership, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data integrity, and safety requirements. Reports to the Director of Quality Control and collaborates with Manufacturing to support production schedules and testing timelines.

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 12 years of quality control experience OR Associate’s degree and 10 years of quality control experience OR Bachelor’s degree and 5 years of quality control experience OR Master’s degree and 3 years of quality control experience OR Doctorate degree.
• Required: In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
• Preferred: Experience working in a GMP-regulated Quality Control laboratory with demonstrated ability to work independently.
• 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.

Education

• Bachelor’s degree in a scientific discipline or equivalent experience.