Senior Associate I, Quality Assurance Specialist
hace 2 meses
We are seeking a highly skilled Senior Associate I, Quality Assurance Specialist to join our Quality Control team at Biogen. As a key member of our team, you will be responsible for contributing to the tactical and operational aspects of our Quality Control group.
Key Responsibilities:
- Performing Quality Control Routine Testing: Execute routine microbiological and/or physico-chemical testing of finished products for commercial release in a cGMP manner.
- Ensuring Regulatory Compliance: Adhere to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key Quality Assurance and Global Quality Control, Supply Chain, Regulatory Affairs, and coordination of investigations impacting Quality areas.
- Providing Technical Support: Offer technical support as a subject matter expert during internal and external inspections.
- Coaching and Continuous Improvement: Coach and continuously improve all Quality Systems cross-functionally.
- Document Authoring and Review: Author or review controlled documents, investigational protocols, investigational reports, change control requests, validation protocols, validation reports, exception reports according to applicable procedures.
- Method Transfer and Development: Lead the execution of method transfer, method development, method qualification, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group.
- Compliance and Quality Systems: Support the management team to ensure that laboratory and Quality systems within the department remain in compliance with Biogen and industry standards.
Qualifications:
- Education: Pharmacy, Chemistry, or Biological Science degree.
- Language: English (intermediate to advanced level - spoken and written).
- Experience: Minimum of 5 years of experience in Quality Control.
- Skills: Distinguished experience with chemistry testing is mandatory. Experience in pharmaceutical companies (human health) is required.
About 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.
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