GMP QA Specialist Onsite Floor Oversight

Global-Technical-Talent-1; West Greenwich (RI); Presencial; USD 32 000 - 36 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Medical, Vision, and Dental Insurance

401k Retirement Fund

Resumo da oferta

GTT is seeking a Senior Associate, QA - GMP to support our West Greenwich, RI manufacturing site. You will perform PQA on the floor during bulk drug substance operations, facilitating real-time quality decisions and deviations in a fast-paced GMP environment.

Key duties include providing quality oversight of manufacturing, reviewing cGMP documents, ensuring records are complete, and alerting management to risks.

Qualificações

• GMP experience required; prior GMP industry preferred.
• Academic background in Sciences.
• Must be a team player; individual contributors not sought.
• Experience with cGMP documentation and batch records.

Responsabilidades

• Provide Quality oversight for Manufacturing operations to ensure CGMP compliance.
• Review and approve cGMP processes, procedures, documents, and records.
• Ensure production records and testing results are complete and accurate.
• Alert management to quality, compliance, risks.
• Work on the floor in clean room space and gowning.

Conhecimentos

cGMP experience

Team player

Communication skills

Data integrity knowledge

Prioritization under ambiguity

Formação académica

High school diploma / GED

Associate degree

Bachelor's degree

Master's degree

Ferramentas

Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams)

Descrição da oferta de emprego

GTT is seeking a Senior Associate, QA - GMP to support our West Greenwich, RI manufacturing site. You will perform PQA on the floor during bulk drug substance operations, facilitating real-time quality decisions and deviations in a fast-paced GMP environment.

Key duties include providing quality oversight of manufacturing, reviewing cGMP documents, ensuring records are complete, and alerting management to risks.