Senior QA Lead – Biologics Contract Manufacturing

LanceSoft Inc; Lexington (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading biotech firm in the United States is looking for a Quality Assurance Professional to oversee contract manufacturing and testing of biologics products. This role requires at least 5 years of experience in a cGMP environment, with strong skills in compliance documentation and Quality Control. The ideal candidate possesses excellent communication abilities and a flexible work ethic. The position provides an opportunity to contribute to quality assurance processes while working collaboratively within a dynamic team.

Qualifications

• Minimum of 5 years in a cGMP biotech and/or pharmaceutical environment.
• Experience in Biologics manufacturing or Quality Control.
• Flexibility and adaptability in a dynamic environment.

Responsibilities

• Perform QA oversight for CMO and CTL in drug manufacturing.
• Interface with CMO and CTL for compliance documentation.
• Compile and track CMO and CTL metrics and deliverables.

Skills

GMP programs

cGMP biotech experience

Quality Control knowledge

Excellent communication skills

Strong business acumen

Organizational skills

Teamwork skills

Job description

A leading biotech firm in the United States is looking for a Quality Assurance Professional to oversee contract manufacturing and testing of biologics products. This role requires at least 5 years of experience in a cGMP environment, with strong skills in compliance documentation and Quality Control. The ideal candidate possesses excellent communication abilities and a flexible work ethic. The position provides an opportunity to contribute to quality assurance processes while working collaboratively within a dynamic team.