Quality Assurance Specialist – cGMP & Compliance

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a Specialist QA to perform a broad range of quality assurance activities under minimal supervision, ensuring compliance with cGMP, internal procedures, and regulatory expectations across on-floor oversight, documentation review, and quality system support.

The role collaborates cross-functionally with Manufacturing, Process Development, Validation, QC, and Facilities to maintain product quality, lead investigations, support audits, and drive continuous

Qualifications

• Excellent knowledge of cGMP and regulatory expectations.
• Experience with deviations, CAPA, and change control.
• Strong English and Spanish communication skills.
• Ability to lead investigations and coordinate with cross‑functional teams.
• Experience validating and reviewing documentation and reports.
• Ability to work independently and manage multiple tasks.
• Will­ingness to participate in audits and inspections.
• Contract role with 6‑month duration.

Responsibilities

• Review and approve product MPs, process validation protocols, and manufacturing reports.
• Perform on‑the‑floor PQA review and tracking of cGMP processes and documents.
• Participate in incident triage, deviation initiation, documentation, and compliance.
• Approve Environmental Characterization reports and release sanitary utilities.
• Lead investigations, audits, and support internal/external inspections.
• Represent QA in NPI activities and provide quality oversight for new products.
• Own and maintain site quality program procedures; act as QA designee.
• Review risk assessments and support automation, facilities, and engineering programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Provide lot disposition and authorize lots for shipment.
• Coordinate testing with contract labs and review external data.
• Support commissioning, qualification, and validation (IQ/OQ/PQ).
• Champion continuous improvement initiatives and training adherence.
• Collaborate cross‑functionally with Manufacturing, Process Development, Validation, QC, and Engineering.

Skills

Quality Assurance

cGMP

Regulatory compliance

Documentation review

Cross-functional collaboration

Investigations leadership

English/Spanish communication

Training and QA programs

Education

Doctorate

Master's + 2 years

Bachelor's + 4 years

Associate's + 8 years

High School/GED + 10 years

Tools

TrackWise

SAP

EDMQ

CAPA systems

Job description

BioPharma Consulting JAD Group is seeking a Specialist QA to perform a broad range of quality assurance activities under minimal supervision, ensuring compliance with cGMP, internal procedures, and regulatory expectations across on-floor oversight, documentation review, and quality system support.

The role collaborates cross-functionally with Manufacturing, Process Development, Validation, QC, and Facilities to maintain product quality, lead investigations, support audits, and drive continuous