QC Chemistry Associate III: Release & Method Leadership

Biogen; North Carolina; On-site; USD 69,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Tuition reimbursement

Job summary

Biogen is seeking a Quality Control Associate III to support the QC Chemistry department in maintaining cGMP compliance and to drive completion of departmental milestones for clinical and commercial product testing. The role involves release/stability testing, investigations, and coordinating test results with chemistry customers to support site and global initiatives.

The successful candidate will perform release and stability testing, write/ review protocols and validation documents, and

Qualifications

• Bachelor’s degree or Associate degree (+2 years lab experience) in biological/chemistry/life sciences
• HPLC experience required
• Knowledge of QC Chemistry release and stability methodology
• Experience with FDA/EMEA regulations and compliance
• Proven instrument/method troubleshooting skills
• Demonstrated problem solving skills

Responsibilities

• Performs release and stability testing and reviews data.
• Authors or reviews investigational protocols and validation reports.
• Supports transfer, qualification, method development, and validation projects.
• Provides technical leadership through project management and investigations.
• Maintains laboratory systems to ensure data integrity.
• Participates in cross-functional site teams and mentors peers.

Skills

HPLC experience

Instrument/method troubleshooting

Quality Control knowledge

FDA/EMEA regulations knowledge

Problem solving

Multi-tasking

Communication skills

GMP experience

Education

Bachelor’s or Associate degree in biological/chemistry/life sciences

Job description

Biogen is seeking a Quality Control Associate III to support the QC Chemistry department in maintaining cGMP compliance and to drive completion of departmental milestones for clinical and commercial product testing. The role involves release/stability testing, investigations, and coordinating test results with chemistry customers to support site and global initiatives.

The successful candidate will perform release and stability testing, write/ review protocols and validation documents, and