On-the-Floor QA Specialist - cGMP Biopharma

BioPharma Consulting JAD Group; Juncos (PR); Presencial; USD 70 000 - 100 000; Tempo integral

Resumo da oferta

BioPharma Consulting JAD Group seeks a Specialist Quality Assurance to provide on-the-floor PQA support for Drug Substance operations at a biopharmaceutical site in Juncos, Puerto Rico. This role ensures manufacturing processes, records and changes meet cGMP requirements and collaborates with Manufacturing, Process Development, Validation, Quality Control and Engineering.

Responsibilities include on-the-floor review of cGMP processes, deviations investigations, and approval of validation

Qualificações

• Bachelor's degree in Science or Engineering required with 4+ years related experience.
• Experience with deviations, CAPA and change control processes.
• Knowledge of cGMP and QA/QC in biopharma.

Responsabilidades

• Perform on-the-floor PQA review, approval and tracking of cGMP processes and records.
• Triage deviations on the floor and ensure investigations per procedure.
• Assess changes potentially impacting product quality per procedures.
• Ensure production records and testing results meet cGMP requirements.
• Support audits and inspections as Quality unit representative.
• Provide QA support for NPI and act as Quality contact for complex projects.
• Review and approve validation deliverables for GxP applications and equipment.
• Champion continuous improvement initiatives.

Conhecimentos

Quality Systems

Deviations

CAPA

Change Control

GxP Applications

Data Trending

Regulatory Interaction

Bilingual English/Spanish

Formação académica

Bachelor's degree in Science or Engineering

Ferramentas

MES

EBR

SAP

TrackWise

Descrição da oferta de emprego

BioPharma Consulting JAD Group seeks a Specialist Quality Assurance to provide on-the-floor PQA support for Drug Substance operations at a biopharmaceutical site in Juncos, Puerto Rico. This role ensures manufacturing processes, records and changes meet cGMP requirements and collaborates with Manufacturing, Process Development, Validation, Quality Control and Engineering.

Responsibilities include on-the-floor review of cGMP processes, deviations investigations, and approval of validation