Pharma Quality Data Reviewer

AbbVie; Worcester (MA); Presencial; USD 59 000 - 99 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Paid time off

Medical/dental/vision insurance

401(k)

Resumo da oferta

AbbVie is seeking an Associate Data Reviewer, QC to support the Quality Function within Operations. The role encompasses GMP data review, incoming quality assurance of drugs and packaging materials, and quality engineering responsibilities.

Responsibilities include on-the-floor and off-the-floor data review, data archiving, and ensuring conformance with AbbVie Quality Systems and regulatory requirements. Collaboration with Management on quality initiatives is expected.

Qualificações

• Bachelor’s degree or 2 years of combined experience in manufacturing, QA, QC, or R&D within the pharmaceutical or biologics industry.
• Working knowledge of electronic document management and laboratory information management systems.
• Familiarity with Quality Systems, cGMP, and other applicable regulatory requirements.

Responsabilidades

• Performs Routine and STAT Review of Lab test data including On-the-Floor Review and Off-the-Floor Review for low complexity test methods.
• Completes review of assays, data mining projects, and archiving of data.
• Responsible for various aspects of quality assurance and quality control related to their functional area.
• Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.

Conhecimentos

Quality Systems knowledge

cGMP familiarity

Regulatory familiarity

Formação académica

Bachelor’s degree or 2+ years pharma/biotech experience

Ferramentas

LIMS

EDMS

Descrição da oferta de emprego

AbbVie is seeking an Associate Data Reviewer, QC to support the Quality Function within Operations. The role encompasses GMP data review, incoming quality assurance of drugs and packaging materials, and quality engineering responsibilities.

Responsibilities include on-the-floor and off-the-floor data review, data archiving, and ensuring conformance with AbbVie Quality Systems and regulatory requirements. Collaboration with Management on quality initiatives is expected.