GMP Quality Assurance Specialist

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

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a highly motivated QA professional to join our team in Puerto Rico & USA. You will review manufacturing records, support CAPA and change controls, and ensure cGMP compliance across processes, documents, and audits.

You will collaborate with Manufacturing, Process Development, Validation and Quality teams to drive product quality and continuous improvement in a world-class manufacturing environment.

Qualifications

• Bachelor's degree in Science or Engineering required.
• Experience in GMP manufacturing QA and quality systems.
• Experience reviewing change controls, deviations, CAPAs, protocols, and procedures.
• Bilingual English/Spanish communication preferred.

Responsibilities

• Perform on-floor PQA reviews of cGMP processes, procedures, testing methods, documents, and production records.
• Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation.
• Triage, investigate, document, and resolve deviations and quality events per cGMP.
• Assess changes for impact to product quality and compliance.
• Support CAPA, change control, validation and other quality system activities.
• Collaborate cross-functionally with Manufacturing, Process Development, Validation, QA, Warehouse, Engineering, Facilities, Environmental, and Contractors.
• Provide QA support for New Product Introduction (NPI) and complex projects.
• Support audits and regulatory inspections as a Quality representative.
• Support commissioning and qualification activities and GxP validation work.
• Analyze quality data and trends; recommend actions to mitigate risks.
• Participate in continuous improvement initiatives and quality projects.
• Communicate quality, compliance, supply, and safety risks to management.
• Work independently while effectively leading and partnering with cross-functional teams.

Skills

Quality Assurance

cGMP

Regulatory compliance

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in Science or Engineering

Tools

TrackWise

SAP

MES/EBR

EDMQ

DQMS

Job description

QUALITY CONSULTING GROUP, LLC is seeking a highly motivated QA professional to join our team in Puerto Rico & USA. You will review manufacturing records, support CAPA and change controls, and ensure cGMP compliance across processes, documents, and audits.

You will collaborate with Manufacturing, Process Development, Validation and Quality teams to drive product quality and continuous improvement in a world-class manufacturing environment.