JT845 - SPECIALIST QA

Quality Consulting Group•Juncos, PR

14d

About The Position

Quality Consulting Group is seeking a Specialist QA to support pharmaceutical, biotech, medical device, and manufacturing operations in Puerto Rico and the United States. The role provides on-the-floor Plant Quality Assurance review and approval of cGMP processes, documentation, testing methods, and production records. It also supports quality systems, validation, audits, regulatory inspections, new product introduction, and continuous improvement activities while partnering with cross-functional teams.

Requirements

Bachelor's degree in Science or Engineering.
Experience with New Product Introduction (NPI) processes.
Knowledge of change control management and documentation.
Experience with Factory Acceptance Tests (FATs).
Knowledge of validation protocols and execution, including equipment and process validation.
Experience supporting Process Performance Qualification (PPQ) activities.
Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
Ability to prepare, review, and maintain technical documentation.

Nice To Haves

Experience working in a pharmaceutical, biotechnology, or medical device manufacturing environment.

Responsibilities

Perform on-the-floor Plant Quality Assurance review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
Review and approve batch records and MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
Ensure deviations and quality events are triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
Review and assess changes for potential impacts to product quality and compliance.
Support and oversee CAPA, change control, validation, and other Quality System activities.
Partner 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 recommend actions 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 leading, influencing, and collaborating with cross-functional teams.