JT768 - SPECIALIST QA

Quality Consulting Group•Juncos, PR

About The Position

QUALITY CONSULTING GROUP, a leader in the 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.

Requirements

Bachelor's degree in Science or Engineering
Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
Experience with batch record review and manufacturing documentation.
Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
Strong analytical, problem-solving, organizational, and project management skills.
Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
Strong English and Spanish written and verbal communication skills.
Proficiency with word processing, presentation, database, and spreadsheet applications.
Ability to evaluate compliance issues and interpret quality data/trends.
Ability to work independently and interact effectively with employees and leadership at all organizational levels.

Nice To Haves

Knowledge of computer systems validation / computer systems quality assurance is highly desirable.

Responsibilities

Perform on-the-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