This position schedule is Monday-Friday business hours, with occasional weekends and holidays as needed for coverage
About This Role
The Quality Control Materials Associate II plays a critical role in supporting the release of raw materials and utility systems used in Biogen manufacturing operations. In this position, you will perform raw material sampling, inspections, testing, utility monitoring, and validation activities while ensuring compliance with GMP and GLP requirements. Working closely with Quality Control leadership, Manufacturing, Quality, and cross-functional partners, you will help maintain the integrity and accuracy of laboratory data that directly impacts material release decisions. Success in this role requires strong scientific fundamentals, attention to detail, technical problem-solving skills, and the ability to manage multiple priorities in a fast-paced GMP environment.
What You'll Do
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 to ensure 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
Required Skills
High school diploma with 2-4 years of Quality Control GMP experience OR Associate's Degree with 1 year of experience OR 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 physical mobility demands as outlined below
Physical Mobility Demands
The incumbent could stand for four (4) hours, walk for three (3) hours, sit for three (3) hours, kneel or bend for one (1) hour, is required to perform upper body twisting motions for one half (½) hour and climb steps for one half (½) hour during the normal course of performing the essential duties of the position.
The incumbent will also be required to lift and move up to 25 pounds and occasionally lift and move up to 50 pounds with assistance for up to 100 feet, occasionally push/pull more than 100 pounds
The incumbent manipulates small objects and performs activities or operates equipment that requires flexion, extension, or movement of the wrist; grasping; manipulation using hands and/or fingers; etc.
The incumbent is required to wear personal protective equipment, such as, safety shoes, safety glasses and/or hearing protection, as well as full gowning in a lab environment for up to 75% of every shift
Preferred Skills
Experience working in a GMP environment
Familiarity with raw materials
Experience referring to and complying with SDS material sheets
Job Level: Entry Level
Additional Information
The base compensation range for this role is: $57,000.00-$74,250.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our…