Specialist QA

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

Biopharma-Consulting-Jad-Group is seeking a Specialist QA to perform broad QA activities under minimal supervision, ensuring cGMP compliance, internal procedures, and regulatory expectations. The role provides on-the-floor oversight, documentation review, and cross-functional quality system support.

You will review and approve MPs, batch records, CAPAs, and change controls; participate in incident triage; support inspections; and help drive continuous improvement with manufacturing, validation,

Qualifications

• Experience with deviations, CAPA, and change control.
• Knowledge of GxP and validation concepts.
• Familiarity with computer systems validation and QA processes.
• Ability to communicate in English and Spanish.

Responsibilities

• Review and approve product MPs, process validation protocols, and manufacturing reports.
• Lead on-the-floor Plant QA 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.

Skills

Quality Assurance

cGMP familiarity

Regulatory knowledge

Cross-functional collaboration

Documentation review

Education

Doctorate

Master's + 2 years of directly related experience

Bachelor's + 4 years of directly related experience

Associate's + 8 years of directly related experience

High School/GED + 10 years of directly related experience

Tools

SAP

MES/EBR

EDMQ

Trackwise

DQMS

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.