New · posted Nov 8
Biogen · Biotechnology
Associate II, Quality Control Materials
- Research Triangle Park, NC
- On-site
- Full-time
- Associate & Specialist
The role
This position schedule is Monday-Friday business hours, with occasional weekends and holidays as needed for coverage
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 need
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
Preferred Skillsnice to have
- Experience working in a GMP environment
- Familiarity with raw materials
- Experience referring to and complying with SDS material sheets
Job Level: Entry Level
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
Pay and benefits
$57,000 – $74,250 a year
Employer providedAdditional 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
Medical, Dental, Vision & Life insurance
401(k) with company match
Employee stock purchase plan
Tuition reimbursement up to $10,000 per year
Paid vacation, holidays and sick time
Paid maternity and parental leave
Where you'll work
Research Triangle Park, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Research Triangle Park, NCWorking conditions
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
From the posting
About Biogen
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.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% below the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in North Carolina5 roles publishing pay
Associate & Specialist roles in the US89 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $57,000 | — | $74,250 |
| North Carolina (middle half) | $65,500 | $74,000 | $81,000 |
| All US (middle half) | $62,500 | $72,000 | $88,500 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 261 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Career resources on Quality Control
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Lab testing and methods5
- Collaboration and leadership4
- Validation and qualification3
- Documentation and SOPs2
- Investigations and CAPA2
- Data and digital systems2
- Quality systems and risk1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studiesNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
Company hiring pulse
Biogen on Regulatory Jobs
- 24
- Open roles
- 24
- Distinct roles
- 4
- Locations
By discipline
- Clinical13 54%
- Quality8 33%
- Regulatory3 13%
By level
- Director7 29%
- Senior & Principal7 29%
- VP & Executive5 21%
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Associate II, Quality Control Materials at Biogen
Open until filled. $57K–$74K a year, employer provided.