Senior Quality Assurance Lead - CGMP & CAPA Expert

Artech Information System LLC; Canton (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing company in Massachusetts is seeking a qualified individual to investigate GMP operations and ensure compliance with regulations. The ideal candidate will have a Master’s or Bachelor’s degree in Engineering or Life Sciences, coupled with extensive experience in Quality and Compliance within the biotechnology or pharmaceutical sectors. Strong investigation, analytical, and leadership skills are essential. The role involves ensuring inspection readiness and supporting audits. Competitive salary and benefits offered.

Qualifications

• Master’s Degree in Science and 5 years of relevant industry experience.
• Bachelor’s Degree in Science and 7 years of relevant industry experience.
• 12+ years relevant industry experience with biologics or pharmaceuticals.

Responsibilities

• Investigate GMP operations deviations and make recommendations.
• Ensure inspection readiness and compliance with CGMP regulations.
• Lead investigation teams and assist in tracking CAPAs.
• Provide support during audits and address observations promptly.

Skills

Investigation of medium and high risk events

Customer focus

CGMP compliance knowledge

Analytical skills

Organizational skills

Communication skills

Interpersonal skills

Leadership abilities

Decision making skills

Education

Master’s Degree in Engineering or Life Sciences

Bachelor’s Degree in Engineering or Life Sciences

12+ years relevant industry experience

Tools

MS Office Applications

Job description

A leading IT staffing company in Massachusetts is seeking a qualified individual to investigate GMP operations and ensure compliance with regulations. The ideal candidate will have a Master’s or Bachelor’s degree in Engineering or Life Sciences, coupled with extensive experience in Quality and Compliance within the biotechnology or pharmaceutical sectors. Strong investigation, analytical, and leadership skills are essential. The role involves ensuring inspection readiness and supporting audits. Competitive salary and benefits offered.