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Investigator II
2 months ago
Job Description
About This Role
This site-based role supports Large Scale manufacturing in Purification, primarily during core weekday business hours, but may require off-hours support.
The Investigator II is responsible for maximizing organizational learning and improvement from Quality deviations. This team applies systematic and analytical cause analysis techniques in direct support of manufacturing operations. The Investigator II applies appropriate methodology for each given situation, facilitates investigation team meetings, conducts interviews, collects data, and synthesizes data to identify causes and casual factors. The Investigator II will support major & critical deviations, collaborating with the Learning Teams to support corrective actions.
What You'll Do
- Leads investigations for Quality deviations and incidents as required. Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements
- Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
- Document investigation reports and findings in designated Quality systems.
- Ensures required management and Quality approvals on final investigations while satisfying established due dates.
- Facilitate corrective and preventive action agreement with stakeholders.
- Facilitates internal sharing of investigational findings and risk knowledge.
- Contributes to metrics related to investigation process and CAPA effectiveness.
- Present investigations during internal and external audits.
- Collaborates cross-functionally to ensure robust investigation conclusions, effective communication, and sharing of learnings
Who You Are
You thrive in an environment that is not pre-scheduled or mundane. You constantly seek to understand and to learn more with minimal guidance. You are comfortable handling and refocusing people from various functions and with various perspectives. You encourage handling the right problem to help the organization improve as a whole; no matter how challenging that fix may be.
Qualifications
Investigator II:
- M.S. degree (STEM preferred) plus a minimum of 5 years of transferrable experience OR
- B.S. degree (STEM preferred) plus a minimum of 8 years of transferrable experience OR
- A.S degree (STEM preferred) plus a minimum of 12 years of transferrable experience
- Experience driving complex and/or high impact investigations in an industrial/plant environment
- Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
Additional Requirements:
- Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
- Ability to interpret technical information and documentation used for operations and production activities.
- Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
- Effective facilitation skills
- Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
- Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
- Experience interpreting technical information and documentation used for operations and production activities.
- Experience balancing resource demands from multiple stakeholder groups including Manufacturing, Quality and Engineering.
- Experience in performance improvement with basis in Human and Organizational Performance principles.
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.
