Quality Control Analyst
About This Role:
As a Quality Control Analyst, you will be a vital member of the Quality Control Lab, contributing to both the independent execution of laboratory activities and collaborative strategic projects. In this mid-level role, your expertise will span across QC Chemistry and Microbiology areas, where you will perform batch release testing and associated activities such as assay & impurities, pH, moisture, and chromatographic analyses. You will be responsible for ensuring robust and compliant cGMP documentation practices, maintaining data integrity, and adhering to GMP requirements to uphold quality standards. Your role will involve supporting equipment and instrument calibration programs, participating in key initiatives with external teams, and providing guidance to team activities as directed by management. Your collaboration will extend to investigations and compliance assessments, utilizing quality tools for managing deviations and corrective actions. Additionally, you will support method validation, author protocols and reports, and contribute to training programs. This position requires a good understanding of Health Authorities' regulations, representing QC in audits and inspections, and the ability to work effectively across all business areas and levels of the organization.
What You'll Do:
- Perform batch release testing in QC Chemistry and Microbiology areas.
- Conduct chromatographic analyses including HPLC and Gas Chromatography.
- Execute microbiological routine tests and microbial limits testing.
- Maintain robust and compliant cGMP documentation practices.
- Support equipment and instrument calibration program.
- Participate in strategic projects and external team initiatives.
- Collaborate in investigations and implement corrective actions.
- Manage deviations, CAPA, Change Control, and other quality tools.
- Support method validation and author protocols and reports.
- Assist and contribute to training programs for employees.
- Represent QC in audits and inspections with Health Authorities.
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Who You Are:
You thrive in an environment where you can work independently yet enjoy collaborating with your team to achieve strategic goals. Your attention to detail and commitment to compliance are evident in your robust documentation practices. You are proactive in identifying areas for improvement and skilled in implementing corrective actions. Your excellent communication skills in both Portuguese and English enable you to effectively represent QC in audits and inspections. You are adaptable and capable of working across all levels of the organization, contributing positively to the team's success.
Required Skills:
- 3+ years of relevant experience in Quality Control.
- Bachelor's degree in Pharmaceuticals or related Science fields.
- Excellent written and verbal communication skills in Portuguese and English (advanced level).
Preferred Skills:
- Master's degree or higher.
Job Level: Professional
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 DE&I efforts.
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.
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)