QC Raw Materials Analyst II

Insight Global; Norton (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Insight Global is seeking a QC Raw Materials Analyst II to support the QA Raw Materials function in a biotech manufacturing environment. This role blends hands-on sampling, inspection, testing, and material release activities for incoming raw materials used in production.

The ideal candidate has 3–6 years of GMP QC experience, strong documentation skills, and the ability to balance lab work with paperwork. Collaboration with Manufacturing, Materials Management, and QA teams ensures timely

Qualifications

• Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific field.
• 3-6 years of pharmaceutical/biotech QC experience in a regulated GMP environment.
• Hands-on raw materials sampling and inspection experience.
• Experience with raw material qualification programs.
• Strong GMP documentation and compliance experience.
• Experience balancing laboratory testing activities with paperwork/documentation.
• Ability to work independently with strong attention to detail.
• Cross-functional collaboration skills.
• Experience with LIMS or similar laboratory systems.

Responsibilities

• Perform routine and non-routine raw material sampling, inspection, and testing.
• Execute incoming raw material evaluations and support material release activities.
• Complete and maintain GMP-compliant documentation in LIMS and other controlled systems.
• Review testing results and records to ensure timely material availability.
• Participate in vendor qualification and raw material risk assessment programs.
• Collaborate with Manufacturing, Materials Management, and Quality Assurance teams.
• Update and revise SOPs, work instructions, and testing methods.
• Maintain training records and complete assigned inspections according to schedule.
• Support audit readiness, inspections, and continuous improvement initiatives.
• Split responsibilities approximately 50% laboratory/raw material activities and 50% documentation/paperwork

Skills

QC testing

Raw materials sampling

GMP documentation

LIMS

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Chemistry or related field

Tools

LIMS

SAP

Veeva

Job description

Insight Global is seeking a QC Raw Materials Analyst II for a leading biotechnology client. This individual will support the Quality Control Raw Materials function by performing hands‑on sampling, inspection, testing, and release activities for incoming raw materials used in manufacturing operations. The role is a blend of laboratory work and GMP documentation, requiring someone who can efficiently balance both testing and compliance responsibilities. The ideal candidate will have strong pharmaceutical QC experience, a solid understanding of GMP requirements, and experience supporting raw material qualification programs. This person will work closely with Manufacturing, Materials Management, and Quality Assurance teams to ensure timely material availability while maintaining the highest standards of quality, compliance, and operational excellence.

Must-Haves:

• Bachelor's degree in Chemistry, Biology, Biochemistry, or related scientific field
• 3-6 years of pharmaceutical/biotech QC experience in a regulated GMP environment
• Hands‑on raw materials sampling and inspection experience
• Experience with raw material qualification programs
• Strong GMP documentation and compliance experience
• Experience balancing laboratory testing activities with paperwork/documentation
• Ability to work independently with strong attention to detail
• Cross‑functional collaboration skills
• Experience with LIMS or similar laboratory systems

Plusses:

• Experience with Veeva
• Experience with SAP
• Additional pharmaceutical manufacturing experience
• Knowledge of Excel, Word, and PowerPoint
• Inspection readiness, audit, or regulatory inspection support experience

Day-to-Day:

• Perform routine and non‑routine raw material sampling, inspection, and testing
• Execute incoming raw material evaluations and support material release activities
• Complete and maintain GMP‑compliant documentation in LIMS and other controlled systems
• Review testing results and records to ensure timely material availability
• Participate in vendor qualification and raw material risk assessment programs
• Collaborate with Manufacturing, Materials Management, and Quality Assurance teams
• Update and revise SOPs, work instructions, and testing methods
• Maintain training records and complete assigned inspections according to schedule
• Support audit readiness, inspections, and continuous improvement initiatives
• Split responsibilities approximately 50% laboratory/raw material activities and 50% documentation/paperwork