Associate II, Quality Control Materials

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

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 employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.