QC Materials Associate II — GMP & Lab Testing

NCBioImpact; Durham (NC); On-site; USD 57,000 - 74,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Vacation and holidays

Job summary

Biogen is seeking a Quality Control Materials Associate II to support release of raw materials and utility systems in manufacturing operations. You will perform sampling, inspections, testing, and validation activities in a GMP/GLP environment, ensuring data integrity and timely material release decisions.

Collaborating with Quality, Manufacturing and cross-functional teams, you will help drive investigations, deviations, and change controls while maintaining compliance and laboratory readiness.

Qualifications

• Must have fundamental laboratory techniques.
• Candidate should manage multiple priorities and meet timelines in a fast-paced GMP environment.
• Strong verbal and written communication skills.

Responsibilities

• Perform raw material sampling, inspections, release testing, cleaning validation, and utility monitoring activities
• Ensure GMP/GLP compliance and site quality requirements
• Author investigation protocols and reports, change control requests, and validation documentation
• Review laboratory data for accuracy and completeness
• Support investigations, deviation management, and corrective actions
• Collaborate with Quality, Manufacturing and cross-functional teams to support schedules
• Maintain laboratory systems ensuring data integrity and inspection readiness
• Participate in projects to improve operational effectiveness and quality

Skills

High school diploma

Associate's Degree

Bachelor's Degree in a scientific area

Fundamental laboratory techniques

Multitasking in fast-paced environment

Verbal and written communication

Cross-functional collaboration

Safety adherence

Education

High school diploma

Associate's Degree

Bachelor's Degree in a scientific discipline

Job description

Biogen is seeking a Quality Control Materials Associate II to support release of raw materials and utility systems in manufacturing operations. You will perform sampling, inspections, testing, and validation activities in a GMP/GLP environment, ensuring data integrity and timely material release decisions.

Collaborating with Quality, Manufacturing and cross-functional teams, you will help drive investigations, deviations, and change controls while maintaining compliance and laboratory readiness.