JT807 - SPECIALIST QA

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, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Perform on-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
• Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
• Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
• Review and assess changes for potential impact to product quality and compliance.
• Support and oversee CAPA, change control, validation, and other Quality System activities.
• Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
• Provide Quality support for New Product Introduction (NPI) and complex projects.
• Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
• Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
• Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
• Participate in and lead continuous improvement initiatives and quality projects.
• Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
• Work independently while effectively leading, influencing, and collaborating with cross-functional teams

Qualifications:

• Bachelor's degree in Science or Engineering
• GMP manufacturing experience in Quality Assurance.
• Experience reviewing and approving Change Controls, Deviations, CAPAs, protocols, reports, and procedures.
• Experience supporting packaging and inspection operations preferred.
• Strong knowledge of Good Documentation Practices (GDP) and electronic quality systems.
• Ability to collaborate effectively with Manufacturing, Engineering, and Process Development teams.
• Bilingual English/Spanish communication skills preferred.
• Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.