Associate II, Quality Control Materials

Biogen•Research Triangle Park, NC

About The Position

The Quality Control Materials Associate II supports the release of raw materials and utility systems used in Biogen manufacturing operations. The role performs raw material sampling, inspections, testing, utility monitoring, and validation activities while maintaining compliance with GMP, GLP, and site quality requirements. The associate works with Quality Control leadership, Manufacturing, Quality, and other cross-functional partners to maintain laboratory data integrity and accuracy and support material release decisions. The position requires scientific fundamentals, attention to detail, technical problem-solving, and the ability to manage multiple priorities in a fast-paced GMP environment. The schedule is Monday through Friday during business hours, with occasional weekends and holidays as needed for coverage.

Requirements

High school diploma with 2–4 years of Quality Control GMP experience, or an associate's degree with 1 year of experience, or a bachelor's degree in a scientific discipline.
Understanding of fundamental laboratory techniques.
Ability to manage multiple priorities and meet timelines in a fast-paced environment.
Strong verbal and written communication skills.
Ability to collaborate effectively across teams and departments.
Ability to adhere to safety requirements.
Ability to meet the stated physical mobility demands, including standing, walking, sitting, bending or kneeling, twisting, climbing steps, lifting and moving items, and occasionally pushing or pulling heavy loads.
Ability to manipulate small objects and operate equipment requiring wrist movement, grasping, and hand or finger manipulation.
Ability to wear personal protective equipment, including safety shoes, safety glasses and/or hearing protection, and full gowning in a lab environment for up to 75% of each shift.

Nice To Haves

Experience working in a GMP environment.
Familiarity with raw materials.
Experience referring to and complying with SDS material sheets.

Responsibilities

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

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term cash bonus and equity incentive opportunities for eligible regular employees.