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Johnson & Johnson Innovative Medicine · 1 day ago

QC Separations Specialist

Wilson, NC

Full-time

Onsite

Senior Level

6+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to developing treatments and pioneering solutions for complex diseases. They are seeking an experienced Separations Specialist to join their Quality Control team, responsible for establishing QC capabilities, method transfer, and ensuring compliance in a GMP-regulated environment.

Pharmaceuticals

Responsibilities

Establish QC Capabilities: Support the build-out of QC laboratory infrastructure and workflows for separations testing

Method Transfer & Validation: Lead comparative testing and transfer of HPLC-based methods for biologics, ensuring compliance with global regulatory standards (FDA, EMA, ICH)

Procedure Development: Author, review, and approve SOPs, work instructions, and technical documentation for separations testing

Technical Expertise: Serve as the subject matter expert for chromatographic techniques; train and mentor incoming QC personnel

Cross-Functional Collaboration: Partner with MSAT, QA, and Operations to ensure seamless method implementation and resolve technical challenges

Compliance & Quality: Maintain adherence to GMP, compendial requirements (USP, EP, JP), and site-specific quality standards. Support regulatory inspections and contribute to observation responses

Continuous Improvement: Identify and implement process improvements to enhance efficiency and robustness of separations testing

Qualification

HPLCMethod validationRegulatory complianceCompendial standardsAnalytical developmentCommunication skillsProblem-solving skillsDetail-orientedOrganizational skills