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.
Responsibilities:
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Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
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Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
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Approve process validation protocols and reports, including PPQs and cleaning validation documentation
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Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
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Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
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Approve Environmental Characterization and environmental monitoring reports
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Release and maintain compliance of sanitary utility systems
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Represent Quality Assurance on New Product Introduction (NPI) teams
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Lead and document investigations, root cause analyses, and CAPA development
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Lead and support site audits, including internal, external, and regulatory inspections
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Own, maintain, and continuously improve site quality program procedures
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Serve as QA Manager designee on the local Change Control Review Board (CCRB)
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Review and approve risk assessments and mitigation strategies
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Support automation systems, including review of validation and change documentation
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Support facilities, utilities, and environmental compliance programs
Qualifications:
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Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.
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Experience in Quality Assurance within a cGMP/GxP manufacturing environment, preferably in the pharmaceutical or medical device industry.
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Experience conducting on-the-floor Plant Quality Assurance (PQA) reviews and supporting manufacturing operations.
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Strong knowledge of cGMP requirements, Quality Systems, manufacturing processes, and documentation practices.
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Proven experience with deviations, CAPAs, change controls, investigations, and compliance assessments.
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Experience with batch record review, MES, EBR, SAP, EDMQ, DQMS, TrackWise, and other quality/manufacturing systems.
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Experience supporting or leading continuous improvement initiatives and projects.
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Experience assessing changes for potential impact to product quality and ensuring compliance with established procedures.
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Experience with Computer System Validation (CSV) and/or Computer Systems Quality Assurance (CSA), preferably within medical devices or other regulated industries.
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Experience with GxP application validation, including Validation Master Plans, Risk Assessments/GxP Assessments, IQ, OQ, PQ, test scripts, and validation summary reports.
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Proven experience in commissioning and qualification activities.
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Experience supporting New Product Introduction (NPI) and complex projects involving new products.
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Strong understanding of manufacturing, distribution, Quality Assurance, Quality Laboratory, and Process Development processes.
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Experience supporting internal and external audits and regulatory inspections, including serving as a Quality Unit representative.
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Ability to interact effectively with regulatory agencies and cross-functional teams.
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Strong leadership, influencing, negotiation, facilitation, and decision-making skills.
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Excellent organizational skills with the ability to manage multiple assignments and follow projects through completion.
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Strong analytical skills, including data trending, evaluation, and compliance assessment.
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Proficiency in Microsoft Word, PowerPoint, Excel, database applications, and other business systems.
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Excellent written and verbal communication skills in English and Spanish.
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Ability to work independently while effectively collaborating with all levels of the organization.
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Strong interpersonal and cross-functional collaboration skills.
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Non-Standard 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.
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