On-Site QA Specialist: cGMP & Validation (6.5m)

Biopharma-Consulting-Jad-Group

Juncos (PR)

On-site

USD 83,000 - 117,000

Full time

4 days ago

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Job summary

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, PR. The role ensures that manufacturing processes, records and changes meet cGMP requirements and partners closely with Manufacturing, Process Development, Validation, Quality Control and Engineering.

The position covers on-site QMS activities, deviation investigations, and validation deliverables while contributing to

Qualifications

Bachelor's degree in Science or Engineering with 4 years of directly related experience.
Experience with deviations, CAPA and change control.
Experience in computer systems validation or computer systems quality assurance.
Experience in commissioning, qualification and validation of GxP applications.
Strong knowledge of manufacturing, distribution, QA and Process Development processes.

Responsibilities

Perform on-the-floor PQA review, approval and tracking of cGMP processes, procedures, documents and records.
Ensure on-the-floor triage of deviations is completed and documented and investigated per procedure.
Assess changes potentially impacting product quality per procedures.
Ensure production records and testing results are complete and compliant with cGMP.
Support internal and external audits, acting as Quality unit representative.