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Sr. Associate I, Quality Assurance
3 months ago
About This Role
The Sr. Quality Assurance Associate I is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management.
What You’ll Do
- Batch Record Review impacting Product Disposition: Review all Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, etc.) for compliance and determine acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
- Exceptions and CAPA: Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of the investigations and provide feedback to the department owner. Support investigations with the ability to analyze the defect and determine potential areas within the process that may have attributed to the defect.
- Controlled Document Workflows: Review of GMP controlled documents to ensure changes and reasons are accurately reflected in the workflow, content is compliant with all applicable regulations and company directives, changes will not have an adverse impact to product quality and setting appropriate release dates.
- Execute activities including technical writing, investigation support (root cause analysis/impact assessment), and project representation.
- Support resolution of both technical and compliance issues/gaps of moderate complexity. Help in implementation of Quality Systems/System Improvements and technical problem solving.
- Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
- Control and release of equipment from maintenance, validation, change control and product changeover.
- Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions.
Who You Are
You are task oriented and focused on continuous improvement. You are curious and eager to learn. You ask copious questions and excel at root/cause analysis. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.
Qualifications- Bachelor’s degree preferably in a field of science or biotechnology.
- A minimum of 4 years relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation.
- General understanding of relevant FDA/EMA regulations and compliance.
- General understanding of the manufacturing process.
- Strong organizational skills.
- General understanding of Quality concepts; able to practice and implement them.
- Ability to develop innovative/creative solutions to issues of moderate complexity.
- Detail oriented aptitude.
- Excellent oral and written communication skills.
Preferred Skills
- Experience in Downstream manufacturing operation.
- Experience with biologics.
- Additional years of experience in quality.
Additional Information
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.
