Clinical Trial Data Analyst

AAKKODIS
active
full-time
on-site
senior-level
Job Description

We are looking for a Senior QC Materials Specialist (Fulltime, 40 hours a week) to join our Akkodis team. Start: A.S.A.P. Duration: Initially 6 months Deadline to apply: 21/07/2025 Job summary Join us as a Senior QC Materials Specialist, where you'll play a pivotal role in ensuring the availability, qualification, and compliance of critical materials that support the manufacturing and testing of life-changing therapies. Reporting into the Global QC Sciences team, you’ll work autonomously while collaborating cross-functionally to establish and maintain the global strategy for raw materials, reagents, reference standards, and assay controls within a GMP-regulated environment. This is an opportunity to directly impact product quality, regulatory compliance, and the timely delivery of therapies to patients around the world.

Requirements

Bachelor’s or Master’s degree in a relevant scientific discipline.

Minimum of 5 years’ experience in the pharmaceutical or biotech industry, preferably within a GMP-regulated QC environment.

Strong expertise in the management and qualification of critical raw materials, reagents, reference standards, and assay controls.

Hands-on experience with material risk assessments, change control processes, and GMP documentation.

Familiarity with biologics, cell therapy, or advanced therapeutic modalities is a strong plus.

Working knowledge of mammalian cell culture is advantageous.

In-depth understanding of global regulatory requirements for material qualification and QC testing.

Self-starter with excellent problem-solving skills and the ability to work independently while engaging a wide range of stakeholders.

Exceptional technical writing and communication skills.

A proactive, solution-driven mindset with a strong focus on quality, compliance, and execution.

Required Skills
GMPQC DocumentationMaterial QualRegulatory AffairsRisk AssessmentCross-functionalBiologics
Job Overview
Posted
10 months ago
Expires
in 9 months
Job Typefull-time
Work Modeon-site
Experiencesenior-level
Locations
United States
Company

AKKODIS

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