Investigator Initiated Research Associate - QA Lead

Pioneer Data Systems; Andover (MA); On-site; USD 85,000 - 115,000; Part time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Job summary

SmartRecruiters, Inc. is seeking an Investigator Initiated Research (IIR) Associate in Andover, MA.

This 12-month contract role with potential extension involves leading investigations for GMP manufacturing, including bio process suites, and generating high-quality reports under the Site Investigations group. The candidate will collaborate with quality and operational teams, apply continuous improvement methods, and bring a strong background in quality systems and regulatory compliance.

Qualifications

• BS or MS in a scientific or engineering discipline with 2–6 years in pharma manufacturing.
• BS + 4-6 years experience or MS + 2-4 years experience in pharmaceutical/biological manufacturing.
• Experience with cGMP and Quality environment.
• Strong coordination, facilitation and writing skills.
• Experience in investigations and ongoing improvement methodologies.

Responsibilities

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues.
• Understand processes and systems involved in biologics manufacture to investigate deviations and root causes.
• Work with quality and operations to develop corrective actions.
• Ensure investigations adhere to quality and compliance standards.
• Develop practices, techniques and evaluation criteria for obtaining results.

Skills

Investigations

Quality Assurance

GMP/cGMP

Root Cause Analysis

Cell Culture

Chromatography

Writing Skills

Facilitation

Coordination

Collaboration

Education

BS or MS in scientific/engineering

Job description

SmartRecruiters, Inc. is seeking an Investigator Initiated Research (IIR) Associate in Andover, MA.

This 12-month contract role with potential extension involves leading investigations for GMP manufacturing, including bio process suites, and generating high-quality reports under the Site Investigations group. The candidate will collaborate with quality and operational teams, apply continuous improvement methods, and bring a strong background in quality systems and regulatory compliance.