Specialist QA

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

The Specialist QA performs a broad range of Quality Assurance activities under minimal supervision, ensuring compliance with cGMP requirements, internal procedures, and regulatory expectations. This role provides on‑the‑floor oversight, documentation review, quality system support, and cross‑functional collaboration to maintain product quality and operational excellence.

FUNCTIONS

• Review and approve product MPs, process validation protocols, and manufacturing reports.
• Perform on‑the‑floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, batch records, MES/EBR, SAP, EDMQ, DQMS, Trackwise documentation, deviations, CAPAs, and validations.
• Participate in incident triage teams and ensure deviation initiation, documentation, and procedural compliance.
• Approve Environmental Characterization reports and release sanitary utility systems.
• Approve planned incidents, NC investigations, CAPA records, and change controls.
• Lead investigations, audits, and support internal/external inspections as part of the audit management team.
• Represent QA in New Product Introduction (NPI) activities and provide quality oversight for new products.
• Own and maintain site quality program procedures; act as designee for QA leadership on CCRB.
• Review risk assessments and support automation, facilities, environmental, and engineering programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Provide lot disposition and authorize lots for shipment.
• Ensure production records and testing results are complete, accurate, and compliant with cGMP.
• Coordinate testing with contract laboratories and vendors; review external lab data for accuracy and compliance.
• Support commissioning, qualification, and validation activities (IQ/OQ/PQ, Validation Master Plans, protocols, test scripts, summary reports).
• Serve as a strategic advisor regarding quality, compliance, supply, and safety risks.
• Champion continuous improvement initiatives, programs, and projects.
• Maintain adherence to assigned training requirements.
• Collaborate cross‑functionally with Manufacturing, Process Development, Validation, QC, Warehouse, Engineering, Facilities, Environmental, Contractors, and other stakeholders.

EDUCATION

• Doctorate OR
• Master’s + 2 years of directly related experience OR
• Bachelor’s + 4 years of directly related experience OR
• Associate’s + 8 years of directly related experience OR
• High School/GED + 10 years of directly related experience.

PREFERRED QUALIFICATIONS

• Experience in Change Control, Documentation Review, Validation, PPQ.
• Demonstrated expertise in Quality Systems (deviations, CAPA, change control).
• Experience with computer systems validation or computer systems QA (medical device or consulting background preferred).
• Strong knowledge of manufacturing, distribution, QA, QAL, and Process Development processes.
• Experience with GxP application validation and compliance documentation.
• Proven ability to lead, influence, and negotiate across teams.
• Strong organizational skills and ability to follow assignments through to completion.
• Ability to interact effectively with regulatory agencies.
• Strong communication skills in English and Spanish (written and oral).
• Advanced data trending, evaluation, and compliance assessment skills.
• Ability to work independently and interact effectively at all organizational levels.

• Administrative shift.
• 6‑month contract with possible extension.