QA Specialist, Drug Substance - 3rd Shift Contract

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 130,000; Part time

Job summary

Biopharma-Consulting-Jad-Group is seeking a QA professional to support Batch Record Review, GMP/GDP documentation, and systems management. You will manage multiple priorities, review validation reports, and support CAPA investigations, change controls, and incident triage.

The role requires strong GMP knowledge, independence, and ability to collaborate with cross-functional teams and regulatory agencies. This is a 9-month contract with potential extension, based in Puerto Rico.

Qualifications

• Must have advanced degree or equivalent related experience as listed.
• Experience in GMP/GDP documentation and regulatory interactions.
• Familiarity with equipment, validation, and process development workflows.

Responsibilities

• Perform comprehensive Batch Record Review for completeness, accuracy, and GMP compliance.
• Review and approve product MPs and change controls.
• Approve process validation protocols and reports for manufacturing processes.
• Lead site audits and risk assessments; participate in DAI and NPI teams.

Skills

Project management

Organizational skills

Cross-functional leadership

Influencing and negotiation

Data trending & evaluation

Regulatory interaction

Documentation & QA

Independent work

Education

Doctorate

Master’s + 2 years related experience

Bachelor’s + 4 years related experience

Associate’s + 8 years related experience

High School/GED + 10 years related experience

Tools

SAP

PAX/eBR

Job description

Biopharma-Consulting-Jad-Group is seeking a QA professional to support Batch Record Review, GMP/GDP documentation, and systems management. You will manage multiple priorities, review validation reports, and support CAPA investigations, change controls, and incident triage.

The role requires strong GMP knowledge, independence, and ability to collaborate with cross-functional teams and regulatory agencies. This is a 9-month contract with potential extension, based in Puerto Rico.