Manager Quality Control I - Nights

Manager Quality Control I position on night shift (Wednesday-Saturday) at a biopharmaceutical manufacturing facility. The role provides operational leadership for quality control laboratory activities, including sample management, analytical testing, and GMP compliance in a regulated environment.

Responsibilities

• Lead night shift QC operations including sample receipt, prioritization, and LIMS data entry
• Serve as primary QC contact for Manufacturing, supporting production schedules and issue resolution
• Independently perform routine and complex analytical testing including STAT testing as required
• Ensure compliant documentation per GDP, GMP, and regulatory requirements
• Support laboratory investigations for deviations and communicate shift-level risks to leadership

Requirements

• High school diploma/GED plus 12 years QC experience, or equivalent education/experience combination
• Direct people management experience or leadership of teams, projects, or programs
• Experience in GMP-regulated quality control laboratory environment
• Demonstrated ability to work independently and handle multiple priorities
• Knowledge of data integrity, GDP, GMP, and 21 CFR Part 11 requirements
• Hands-on analytical testing experience in chemistry, bioassay, or microbiology
• Proficiency with laboratory information systems (LIMS, Biovia, Veeva Vault)