JT669 - SPECIALIST QA

Quality Consulting Group•Juncos, PR

3d•Onsite

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 Engineering, Life Sciences, Quality, or a related field.
Experience in Quality Assurance within a cGMP/GxP manufacturing environment, preferably in the pharmaceutical or medical device industry.
Experience conducting on-the-floor Plant Quality Assurance (PQA) reviews and supporting manufacturing operations.
Strong knowledge of cGMP requirements, Quality Systems, manufacturing processes, and documentation practices.
Proven experience with deviations, CAPAs, change controls, investigations, and compliance assessments.
Experience with batch record review, MES, EBR, SAP, EDMQ, DQMS, TrackWise, and other quality/manufacturing systems.
Experience supporting or leading continuous improvement initiatives and projects.
Experience assessing changes for potential impact to product quality and ensuring compliance with established procedures.
Experience with Computer System Validation (CSV) and/or Computer Systems Quality Assurance (CSA), preferably within medical devices or other regulated industries.
Experience with GxP application validation, including Validation Master Plans, Risk Assessments/GxP Assessments, IQ, OQ, PQ, test scripts, and validation summary reports.
Proven experience in commissioning and qualification activities.
Experience supporting New Product Introduction (NPI) and complex projects involving new products.
Strong understanding of manufacturing, distribution, Quality Assurance, Quality Laboratory, and Process Development processes.
Experience supporting internal and external audits and regulatory inspections, including serving as a Quality Unit representative.
Ability to interact effectively with regulatory agencies and cross-functional teams.
Strong leadership, influencing, negotiation, facilitation, and decision-making skills.
Excellent organizational skills with the ability to manage multiple assignments and follow projects through completion.
Strong analytical skills, including data trending, evaluation, and compliance assessment.
Proficiency in Microsoft Word, PowerPoint, Excel, database applications, and other business systems.
Excellent written and verbal communication skills in English and Spanish.
Ability to work independently while effectively collaborating with all levels of the organization.
Strong interpersonal and cross-functional collaboration skills.

Responsibilities

Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
Approve process validation protocols and reports, including PPQs and cleaning validation documentation
Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
Approve Environmental Characterization and environmental monitoring reports
Release and maintain compliance of sanitary utility systems
Represent Quality Assurance on New Product Introduction (NPI) teams
Lead and document investigations, root cause analyses, and CAPA development
Lead and support site audits, including internal, external, and regulatory inspections
Own, maintain, and continuously improve site quality program procedures
Serve as QA Manager designee on the local Change Control Review Board (CCRB)
Review and approve risk assessments and mitigation strategies
Support automation systems, including review of validation and change documentation
Support facilities, utilities, and environmental compliance programs