QC Materials Specialist II – GMP Lab & Release

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) matching

Tuition reimbursement

Job summary

Biogen in the United States is seeking a Quality Control Materials Associate II to support the release of raw materials and utility systems used in Biogen manufacturing operations. You will perform raw material sampling, inspections, testing, utility monitoring, and validation activities while ensuring GMP and GLP compliance and data integrity.

You will collaborate with Quality, Manufacturing, and cross-functional teams to maintain data accuracy, author investigations, and support deviations and

Qualifications

• High school diploma with 2-4 years GMP experience or an Associate/Bachelor in a scientific discipline
• Understanding of fundamental laboratory techniques
• Ability to manage multiple priorities in a fast-paced GMP environment
• Strong verbal and written communication skills
• Ability to collaborate across teams and adhere to safety requirements
• Demonstrated physical mobility and handling of PPE requirements

Responsibilities

• Perform raw material sampling, inspections, release testing, cleaning validation, and utility monitoring
• Ensure compliance with GMP, GLP, and site quality requirements
• Author investigations, change controls, and validation documentation
• Review laboratory data for accuracy, completeness, and compliance
• Support investigations, deviations, and corrective actions
• Partner with Quality, Manufacturing, and cross-functional teams to support schedules
• Maintain laboratory systems ensuring data integrity and inspection readiness
• Participate in projects to improve operations, compliance, and quality

Skills

Laboratory techniques

Communication skills

Team collaboration

Safety compliance

Mobility requirements

Education

High school diploma with GMP experience or related degree

Job description

Biogen in the United States is seeking a Quality Control Materials Associate II to support the release of raw materials and utility systems used in Biogen manufacturing operations. You will perform raw material sampling, inspections, testing, utility monitoring, and validation activities while ensuring GMP and GLP compliance and data integrity.

You will collaborate with Quality, Manufacturing, and cross-functional teams to maintain data accuracy, author investigations, and support deviations and