Senior Specialist, Sterility Assurance
Reykjavik Headquartersonsitesenior
Posted 1w ago · via Workday
About this role
Key responsibilities and minimum requirements according to job level: Contribute to the documentation and management of microbial control strategy for DS and DP production processes from Incoming good to final product. Provide Sterility assurance and Microbiology expertise to operations to ensure manufacturing meets cGMP standards and regulatory expectations. Provides oversight to facility and quality systems state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes. Provides microbial and aseptic expertise to lead and support EMI, Deviations, CAPAs and complaints related to DS and DP manufacturing. Supports site internal inspections, Regulatory and Client audits.…
What we'd score you on
reqspace match rubricFive dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.
1
Skills match
For this role: less
2
Level fit
This role is senior-level. We check your trajectory against it.
3
Domain experience
Your work in the role's domain matters more than your years total. We weight recent and direct experience.
4
Recency
A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.
5
Location fit
This role is based in Reykjavik Headquarters. We weight your proximity and willingness to relocate.
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