SUMMARY

Seeking a QC Technical Lead to serve as the subject matter expert for testing, troubleshooting, and method development in Molecular Biology and Microbiology. This role drives technical excellence, compliance, and continuous improvement across multi-site operations, supporting method transfers, NPI, and regulatory readiness.

EDUCATION

• Doctorate OR
• Master’s + 2 years directly related experience OR
• Bachelor’s + 4 years directly related experience OR
• Associate’s + 8 years directly related experience OR
• High School/GED + 10 years directly related experience

COMPETENCIES / SKILLS

• Demonstrated alignment with our client values and regulated environment values.
• Excellent communication, facilitation, and presentation skills.
• Strong technical writing and documentation expertise.
• Advanced computer skills (Word, PowerPoint, Excel, databases, spreadsheets).
• Project management and organizational skills; ability to follow complex instructions through to completion.
• Ability to manage multiple priorities, shifting focus as needed.
• Expert knowledge of QC analytical labs, validation, manufacturing, QA, process development, and distribution.
• Extensive knowledge of testing, assay development, and validation; ability to perform testing in area of responsibility.
• Strong understanding of pharmaceutical processes and U.S. regulations for pharmaceutical/biological testing.
• Knowledge of international regulations and global quality practices.
• Extensive knowledge of GMPs/CFRs with ability to evaluate compliance issues.
• Proficiency in equipment operation, troubleshooting, and maintenance.
• Advanced scientific data analysis, trending, and problem-solving skills.
• Ability to work independently and collaborate effectively across organizational levels.
• Experience interacting with regulatory agencies, orally and in writing.
• Skilled in leading, motivating, and influencing cross-functional teams.

• Lead technical troubleshooting and resolve complex assay issues.
• Support method transfers and technical services for New Product Introductions (NPI).
• Develop, revise, and audit controlled documents (SOPs, protocols, technical reports) with multi-site impact.
• Approve lab investigations and lead audit teams ensuring GMP/GLP compliance.
• Serve as SME for technical training and laboratory best practices.
• Represent QC in cross-functional teams, multi-site initiatives, and regulatory interactions.
• Implement programs, processes, and methodologies that enhance compliance and operational performance.
• Mentor and guide analysts, providing technical oversight.