Senior QC Specialist - Raw Materials (Onsite)

Moderna Therapeutics; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being programs

Family planning benefits

Generous paid time off

Job summary

Moderna Therapeutics in Norwood, MA is seeking a QC professional to perform Raw Material QC activities in support of GMP manufacturing and special projects. This is a first shift, Monday–Friday (5 x 8hrs).

You will oversee prioritization and release of raw materials, review raw data and supplier documentation, perform specification reviews, and support continuous improvement, audits, and CAPA processes. The role requires a BS in a relevant scientific discipline with 6+ years of experience (or 8+

Qualifications

• BS in a relevant scientific discipline.
• Experience: 6+ years with BS or 8+ years in GMP QC laboratory.
• Strong understanding of GxP, regulations and problem solving.

Responsibilities

• Oversight of prioritization and release of raw materials to meet metrics and turnaround times.
• Review of Raw Data, supplier certification and incoming documentation to meet requirements.
• Specification review and approval.
• Support Continuous Improvement of lab operations.
• Audit support during Regulatory and Health Authority Inspections.
• Train and perform testing for methods including HPLC, Bioanalyzer, osmolality, pH, conductivity, TruScan.
• LIMS (LabVantage) sample logging and result entry.
• Complete and maintain cGMP documentation; participate in deviations, CAPAs.

Skills

GxP knowledge

Audits & inspections

Problem solving

QA documentation

Data review

HPLC

Bioanalyzer

pH measurement

Conductivity

Education

BS in a relevant scientific discipline

Tools

LIMS (LabVantage)

Job description

Moderna Therapeutics in Norwood, MA is seeking a QC professional to perform Raw Material QC activities in support of GMP manufacturing and special projects. This is a first shift, Monday–Friday (5 x 8hrs).

You will oversee prioritization and release of raw materials, review raw data and supplier documentation, perform specification reviews, and support continuous improvement, audits, and CAPA processes. The role requires a BS in a relevant scientific discipline with 6+ years of experience (or 8+