QC Raw Materials Scientist, Primary Packaging

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a scientist with expertise in raw materials and primary packaging for drug product manufacturing. You will support QC Raw Materials and collaborate on tech transfers for new customers and products at FUJIFILM Biotechnologies.

Ideal candidates have advanced GMP knowledge, strong writing and communication skills, and experience interacting with customers and cross-functional teams. Onsite work in Holly Springs, NC is required.

Qualifications

• Master’s degree in Life Sciences or Engineering and 4+ years of GMP QA experience.
• 5+ years in the pharmaceutical industry, preferably with starting materials and primary packaging.
• Experience with regulatory requirements for materials and quality systems.

Responsibilities

• Author testing strategies and specifications for primary packaging, disposables, and raw materials.
• Write and update SOPs for DS/DP material areas.
• Represent QC Raw Materials in tech transfer projects and customer interactions.
• Drive continuous improvements across processes and challenge status quo.
• Perform additional duties as assigned.

Skills

Regulatory knowledge (cGMP/USP/EP/ICH)

Quality control operations

Regulatory interpretation with risk

Technical writing

Stakeholder management

Education

Master's degree in Life Sciences or Engineering

Tools

Microsoft Office

Smartsheet

LIMS

SAP

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a scientist with expertise in raw materials and primary packaging for drug product manufacturing. You will support QC Raw Materials and collaborate on tech transfers for new customers and products at FUJIFILM Biotechnologies.

Ideal candidates have advanced GMP knowledge, strong writing and communication skills, and experience interacting with customers and cross-functional teams. Onsite work in Holly Springs, NC is required.