Specialist Quality Control

Responsibilities

• Serve as a technical expert for testing, method development, and troubleshooting in molecular biology and microbiology.
• Provide technical guidance to QC and cross-functional teams to ensure effective communication across sites.
• Troubleshoot and resolve complex assay-related issues and perform advanced data analysis and trending.
• Ensure laboratory compliance with GMP, GLP, safety, and regulatory expectations.
• Develop, revise, and audit complex controlled documents with multi-site or multi-functional impact.
• Lead laboratory investigations, approve documentation, and lead audit teams.
• Support method validation, qualification, and transfer activities.
• Represent QC on cross-functional teams and manage special projects assigned by leadership.

Requirements

• Doctorate OR Master’s + 2 years of related experience OR Bachelor’s + 4 years of related experience OR Associate’s + 8 years of related experience OR HS/GED + 10 years of related experience.
• Extensive knowledge of analytical testing, assay development, and method lifecycle activities.
• Strong understanding of pharmaceutical/biological product testing and GMP/CFR regulatory expectations.
• Proficiency in equipment operation, troubleshooting, and maintenance within the area of expertise.
• Strong technical writing skills for reports, investigations, and regulatory documentation.

Preferred Qualifications

• Scientific background in Biochemistry, Chemistry, or Microbiology.
• Experience in method validation, method transfer, and method qualification.
• Strong project management capability and ability to work with multi-functional teams.
• Fluency in both English and Spanish.

Benefits

• 6-month contract with the possibility of extension.