Senior Quality Control Associate
hace 2 meses
As a Senior Quality Control Associate, you will play a pivotal role in the operational and tactical functions of the Quality Control team within our organization. Your responsibilities will encompass:
- Conducting routine quality control assessments and managing all associated activities in compliance with current Good Manufacturing Practices (cGMP), including microbiological and physico-chemical evaluations of products intended for market release.
- Ensuring compliance with all regulatory requirements and serving as a subject matter expert across various disciplines, collaborating with key stakeholders in Quality Assurance, Global Quality Control, Supply Chain, and Regulatory Affairs to coordinate investigations that affect quality.
- Providing expert technical assistance during both internal and external audits.
- Facilitating coaching and promoting continuous improvement initiatives across all Quality Systems.
- Drafting and reviewing controlled documents, including investigational protocols, reports, change control requests, and validation documents, in accordance with established procedures.
- Leading method transfer, development, qualification, and analytical improvement projects in partnership with the Analytical Technology/Development team.
- Assisting management in maintaining compliance of laboratory and Quality systems with both company and industry standards.
- Degree in Pharmacy, Chemistry, or Biological Sciences.
- Proficiency in English (intermediate to advanced level, both spoken and written).
- A minimum of 5 years of experience in Quality Control.
- Extensive experience in chemistry testing is essential.
- Experience within the pharmaceutical sector (human health) is mandatory.
At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established organization while encouraging individual contributions that make a significant impact. Our team consists of highly skilled and passionate professionals who enjoy unparalleled opportunities for growth and skill enhancement. Together, we strive to deliver transformative medicines, with every role being crucial to our mission.
We are committed to cultivating an inclusive and diverse workplace that reflects the communities we serve. We believe that a variety of backgrounds, cultures, and perspectives strengthens our organization and drives innovation. Our focus is on building teams where every employee feels valued and inspired.
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