Specialist, Quality Control (Molecular Biology & Microbiology)

Position Summary

Under general direction, the Specialist, Quality Control serves as a technical expert in molecular biology and microbiology testing and development. This role focuses on resolving complex technical challenges and supporting multi-site and cross-functional initiatives, ensuring compliance with regulatory standards and driving continuous improvement within quality control laboratory operations.

Key Responsibilities

• Provide technical leadership and guidance across laboratory functions, ensuring effective communication between cross-functional and multi-site teams
• Perform advanced data analysis, generate reports, and ensure timely resolution of technical issues
• Troubleshoot and resolve complex assay-related challenges
• Ensure laboratory compliance with GMP, GLP, and safety standards, implementing improvements as needed
• Develop, implement, and optimize laboratory programs, processes, and methodologies
• Author, revise, and audit complex controlled documents with potential multi-site impact
• Lead and approve laboratory investigations, ensuring thorough root cause analysis and compliant documentation
• Serve as Subject Matter Expert (SME) and support development of technical training programs
• Represent Quality Control on cross-functional teams and drive completion of multi-site action items
• Interface with regulatory agencies, including preparation of written responses and participation in audits
• Lead internal and external audit activities and resolve issues with external partners/vendors
• Support special projects and continuous improvement initiatives
• Provide supervision or technical oversight of personnel as required

Education & Experience

• Doctorate (PhD) OR
• Master’s degree + 2 years of related experience OR
• Bachelor’s degree + 4 years of related experience OR
• Associate’s degree + 8 years of related experience OR
• High School Diploma/GED + 10 years of related experience

Core Competencies

• Strong understanding of GMP, GLP, CFR, and global regulatory requirements
• Extensive experience in analytical testing, assay development, and validation
• Advanced scientific data analysis, trending, and interpretation skills
• Strong technical writing and documentation skills
• Excellent communication, facilitation, and presentation abilities
• Proven ability to lead cross-functional teams and manage multiple priorities
• Strong problem-solving and decision-making capabilities
• Proficiency in laboratory equipment operation, maintenance, and troubleshooting
• Ability to interact effectively with regulatory agencies and stakeholders

Preferred Qualifications

• Strong expertise in scientific data analysis and trending (Excel-based tools)
• Bilingual technical writing skills (English & Spanish)
• Experience in Computer System Validation (CSV) and Method Validation
• Knowledge of equipment validation and troubleshooting
• Experience with quality systems and process management
• Familiarity with Kneat platform and Kaye Validator (preferred)
• Strong project management and prioritization skills in fast-paced environments
• Ability to develop inspection/qualification protocols under tight timelines
• Strong negotiation and stakeholder management skills

Why Join Us

This role offers the opportunity to work on high-impact, technically complex projects in a regulated environment, contributing to the development and quality of critical pharmaceutical and biological products while collaborating across global teams.