QC Materials Analyst II - GMP & Material Release

Biogen; North Carolina; On-site; USD 57,000 - 74,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Vacation

Holidays

Job summary

Biogen in North Carolina seeks a Quality Control Materials Associate II to support raw material release, sampling, testing and validation in a GMP setting. You will collaborate with Quality, Manufacturing and cross-functional teams to ensure data integrity and timely material release decisions.

Ideal candidates have a science background with 2–4 years QC GMP experience or an appropriate degree, strong organizational skills, and the ability to manage multiple priorities in a fast-paced

Qualifications

• Requires 2-4 years of QC GMP experience or an equivalent science background.
• Strong attention to detail and data integrity required.
• Ability to manage multiple priorities in a fast-paced GMP environment.

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 compliance
• 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

Fundamental lab techniques

Multitasking

Verbal and written communication

Cross-functional collaboration

Safety compliance

Mobility requirements

Education

High school diploma with QC GMP experience (2-4 yrs)

Associate’s Degree with 1 year experience

Bachelor’s Degree in a scientific discipline

Job description

Biogen in North Carolina seeks a Quality Control Materials Associate II to support raw material release, sampling, testing and validation in a GMP setting. You will collaborate with Quality, Manufacturing and cross-functional teams to ensure data integrity and timely material release decisions.

Ideal candidates have a science background with 2–4 years QC GMP experience or an appropriate degree, strong organizational skills, and the ability to manage multiple priorities in a fast-paced