Associate Quality Control - Nights

About This Role

Execute night shift Quality Control activities, including sample receipt and analytical testing, ensuring compliance with GMP, data integrity, and safety requirements within a biopharmaceutical manufacturing setting.

Responsibilities

• Execute QC night shift activities with the night shift team lead
• Perform sample receipt, prioritization, and accurate entry into LIMS
• Conduct routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing
• 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

Requirements

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

Qualifications

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

Nice to Have

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

Skills

* Required skills