Quality assurance analyst jobs in Puerto Rico - 86 jobs

Job Description We are seeking a motivated and detail-oriented Pentester Junior to join our cybersecurity team. The ideal candidate will support penetration testing activities to identify vulnerabilities in systems, networks, and applications. This role involves learning and applying ethical hacking techniques, documenting findings, and collaborating with senior security staff to enhance the organization's overall security posture. The position is ideal for individuals beginning their cybersecurity career who demonstrate strong analytical thinking, curiosity, and a commitment to continuous learning. Responsabilities and Duties: Perform penetration testing activities under supervision, including vulnerability identification, exploitation, and documentation. Stay up-to-date on emerging cybersecurity threats, vulnerabilities, and attack techniques. Assist in researching and developing new penetration testing methodologies, scripts, and tools. Conduct remote or onsite penetration tests to assess system and network security. Simulate security breaches to evaluate the effectiveness of existing security controls. Prepare detailed reports outlining findings, risk levels, and recommended remediation strategies. Present findings and risks to management and relevant stakeholders in a clear and professional manner. Collaborate with the security team to improve organizational security posture. Evaluate and communicate the business impact of identified vulnerabilities. Maintain a professional and ethical approach while performing security assessments. Qualifications: Bachelor's degree in cybersecurity, information technology, computer science, or a related field. No prior penetration testing experience required. Strong understanding of cybersecurity principles, defensive strategies, and attack concepts. Familiarity with common security tools and technologies (e.g., Nmap, Burp Suite, Kali Linux). Basic knowledge of computer networks, protocols, and operating systems. Excellent problem-solving and analytical skills. Strong verbal and written communication abilities. Ability to work independently and collaboratively within a team. Ability to manage multiple tasks, work under pressure, and meet established deadlines. Security certifications such as Security+, CEH, OSCP are preferred but not required. We are an Equal Opportunity Employer (EOE/M/F/V/D). Job Type: Full-time Pay: 25,000.00-35,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Retirement plan Vision insurance Work Location: In person M-F 8AM-5PM

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control). Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP. Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements. Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications. Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.+ Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish. Qualifications Requirements/Knowledge/Education/Skills: BS in Life Science and/or Engineering. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group 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.

Hi, I hope you are doing good. I have a job opportunity related to your profile with one of our client, please find below Job Description for your review. If you are interested and available for the following position then please send your updated resume in word format along with your contact details to discuss further Role:Test Analyst - Web Testing and Automation Duration: Full TIme Location: Aguadilla, PR Qualifications Basic • Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. • At least 2 years of experience with Information Technology Preferred • Minimum 3 years of core Healthcare domain expertise within the Testing experience including HCR, Medicare/Medicaid, Compliance, HIPPA, HealthCare Exchange (HIX) • Minimum 3 years of hands on experience with web application & .Net batch application testing and Minimum 1 year of hands on experience in creating medium to high complexity SQL queries. • Strong automation expertise including scripting, maintenance, mentoring, with minimum 2 years hands on experience in Java/selenium or QTP or RFT automation test framework. Should have experience in developing automation for web, Mobile (hybrid and Native apps) and Web service (Includes web Services and APIs); Automation troubleshooting for team • Expertise in Functional testing, analysis and reporting skills; Expertise on Software Testing Life Cycle Methodologies like waterfall, Agile Delivery and exposure to various testing estimation models • Liaison with client for future work, recommendation, footprint expansion, resource planning and identification; PoC ideation, creation and demonstration to client • Analytical and Communication skills • Experience and desire to work in a Global delivery environment Qualifications • Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. Additional Information All your information will be kept confidential according to EEO guidelines.

Title: Specialist QA (Regulated Industry) - Req. 3517986 Positions Available: 1 Contract Duration: Approximately 5 months Contract through: ProQuality Network Summary As a Specialist QA, you will perform one or more duties in support of Amgen's Quality Assurance program with minimal supervision. This role ensures compliance with regulatory standards and supports quality operations in a regulated manufacturing environment. Preferred Qualifications Experience with NPI (New Product Introduction) Change Control management FAT (Factory Acceptance Testing) Validation and PPQ (Process Performance Qualification) Key Responsibilities / Functions Review and approve product Master Production Records (MPs) Approve process validation protocols and reports for manufacturing processes Participate in incident triage as requested by Quality Approve Environmental Characterization reports Release sanitary utility systems Approve planned incidents and deviations Represent QA on NPI teams Lead investigations and root cause analyses Conduct and lead site audits Maintain ownership of site quality program procedures Serve as designee for QA Manager on local CCRB Review risk assessments and provide guidance Support automation initiatives Support facilities and environmental programs Review and approve Work Orders Review and approve EMS/BMS alarms Approve nonconformance (NC) investigations and CAPA records Approve change controls Provide lot disposition and authorize shipment Education Requirements Doctorate OR Master's degree + 2 years of directly related experience OR Bachelor's degree + 4 years of directly related experience OR Associate's degree + 8 years of directly related experience OR High School/GED + 10 years of directly related experience Competencies / Skills Project management and organizational skills, with the ability to follow assignments through completion Ability to initiate and lead cross-functional teams Strong leadership, influencing, and negotiation skills Expert knowledge in QA, QAL, validation, and process development Experience interacting with regulatory agencies Proficiency in word processing, presentation, database, and spreadsheet applications Strong written and oral communication, facilitation, and presentation skills Ability to work independently and effectively collaborate at all organizational levels Advanced data trending and evaluation capabilities Ability to assess compliance issues accurately Demonstrated alignment with Amgen Values and Leadership Practices This is a contract position through ProQuality Network. We encourage interested candidates to apply directly through the job description link with an updated resume for consideration.

Arival Bank International Corp. is a US-based digital bank licensed and regulated by OCIF. After obtaining our US-based banking license at the beginning of 2021, we officially went live in June 2021 and have onboarded 650+ B2B customers from over 60+ countries. Equipped with forward-thinking compliance, Arival is on a mission to become the go-to digital bank for corporate and institutional clients all over the world. We're actively growing our international team with offices in Puerto Rico, Europe, and Singapore, with over 60+ employees, and building many departments from the ground up. EVERYDAY TASKS:Manual and auto testing of company's products. Reviewing functional requirements, technical design documents and providing meaningful feedback. Writing and supporting test documentation (test plans, test cases and checklists). Identifying, troubleshooting, and tracking bugs to resolution. Supporting existing products and improving them. Working closely with our product team. JOB REQUIREMENTS:Knowledge of software testing theory. Understanding the software development life cycle. Understanding the architecture of client-server and web applications. Experience in functional, API, WEB (or mobile) applications testing. Understanding frontend and backend testing approaches and the ability to apply them. Ability to write test documentation. Ability to analyze business and functional requirements. Fluency in Scrum and Agile methodologies. Experience troubleshooting and debugging production issues. 3+ years of commercial development experience. Solid understanding of the whole web stack and how all the pieces fit together (front-end, server-side, database, network layer, etc. ). Native to the startup world, used to its dynamic, fast-paced and demanding environment. Deep knowledge and understanding of fintech. DESIRED QUALIFICATIONS:Upper Middle or Senior level. Bachelor's degree in relevant field. Master's degree and/or relevant certifications are a plus. Digital banking and/or fintech experience is preferred. Strong knowledge of banking operations processes. A creative approach, with the ability to anticipate challenges and develop innovative solutions. Ability to confidently collaborate with a range of colleagues and departments across our organization as well as working solo. Strong communicative and presentation skills. Ability to identify key themes and communicate relevant insights that drive decision making Good communication skills, written and verbal with the ability to simplify data and build recommendations based on insights gathered. Willingness to work across different time zones with global and regional teams BENEFITS:Join our international team of visionaries in startup attire. Enjoy a highly diverse and international culture. An opportunity to build future, freedom to work anywhere you want. Fair pay, no matter where you live along with a competitive benefits package. Health, dental, and vision insurance. Disability benefits. 401(k) plan with corporate matching. Computer setup of your choice. Generous paid time off to relax and recharge. Opportunity to work in a growing mission-driven startup.

Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: CQV Specialist - Smoke Testing / Airflow Visualization Overview The CQV Specialist for Smoke Testing is responsible for developing, executing, and documenting airflow visualization studies in support of cleanroom and equipment qualification. This role verifies unidirectional airflow, identifies turbulence zones, and ensures compliance with Annex 1 airflow requirements for sterile manufacturing. Key Responsibilities Plan and execute smoke studies (airflow visualization) for cleanrooms, RABS, isolators, filling lines, and critical Grade A/B environments. Set up and qualify smoke/fog generation equipment, lighting, and video recording systems. Document airflow patterns to identify turbulence, dead spots, reverse flows, and compliance gaps. Support qualification activities including FAT/SAT, IQ/OQ, and room qualification for HVAC systems. Write protocols (airflow visualization plans, IQ/OQ protocols) and prepare final reports with photographic/video evidence. Interface with Engineering, Facilities, QA, and Aseptic Operations to resolve airflow issues. Lead deviations, risk assessments, and CAPAs related to airflow or equipment performance. Ensure compliance with ISO 14644-1/2, EU Annex 1 airflow requirements, and ASTM E2500. Support regulatory inspection readiness and provide airflow-related technical responses. Required Qualifications Bachelor's in Mechanical Engineering, Industrial Engineering, Life Sciences, or related field. 5+ years of experience in CQV, HVAC qualification, or aseptic facility commissioning. Strong understanding of airflow dynamics, HEPA performance, differential pressure control, and cleanroom classification. Experience with IQ/OQ execution for cleanroom equipment, isolators, and RABS. Ability to interpret airflow patterns and provide engineering recommendations. Preferred Skills Experience with particle counters, differential pressure monitoring, BMS/EMS systems. Experience qualifying sterile filling lines or aseptic equipment. Knowledge of HVAC balancing, cleanroom design, and environmental controls.

**_What Application Development & Maintenance contributes to Cardinal Health_** Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Application Development & Maintenance performs configuration or coding to develop, enhance and sustain the organization's software systems in a cross-functional team environment through adherence to established design control processes and good engineering practices. This job family programs and configures end user applications, systems, databases and websites to achieve the organization's internal needs and externally-facing business needs. Application Development & Maintenance partners with business leaders, investigates user needs and conducts regular assessments, maintenance and enhancements of existing applications. The SAP Software Engineer focused on Data Conversions, Data Quality, and Reporting is responsible for designing, developing, and maintaining data solutions that ensure data integrity and enable effective business intelligence. The role combines technical skills in data migration and ETL processes with an understanding of data governance and reporting tools. **_What is expected of you and others at this level_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems + Solutions are innovative and consistent with organization objectives + Completes work; independently receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as a mentor to less experienced colleagues **_Responsibilities_** + Design and execute data conversion strategies for SAP implementations and upgrades, including data extraction, transformation, and loading (ETL) from legacy systems into SAP. + Utilize SAP data migration tools such as SAP Data Services, LSMW, and Migration Cockpit to perform data loads and conversions. + Develop and maintain technical specifications, data mapping documents, and transformation rules. + Collaborate with business and technical teams to gather data requirements and ensure seamless data flow across systems. + Establish and maintain data quality frameworks to ensure the accuracy, consistency, and integrity of master and transactional data in SAP. + Perform data profiling, cleansing, and validation to identify and resolve data discrepancies before and after migration. + Define and monitor data quality metrics and key performance indicators (KPIs). + Work with business data stewards to correct data quality issues and promote data governance policies and standards. + Design, develop, and implement reporting solutions, dashboards, and analytical models using SAP technologies like SAP Analytics Cloud (SAC), SAP BW/4HANA, or SAP Fiori. + Translate business needs into technical specifications for reports and ad-hoc queries. + Optimize report performance and data extraction processes for efficiency. + Provide support and training to end-users on reporting tools to enable data-driven decision-making **_Qualifications_** + Bachelor's Degree in related field preferred or equivalent work experience preferred + Proven experience in SAP Data Conversions, migrations and ETL processes. + Proficiency with SAP data tools such as SAP Data Services, SAP BW/HANA or SAP Analytics Cloud + Strong knowledge of SQL, data modelling and database concepts + Experience with SAP modules and data structures (e.g., Master Data, Financials, Supply Chain, OTC, PTP processes). + Excellent analytical, problem solving and communication skills + Ability to work both independently and collaboratively with cross-functional teams **Anticipated salary range:** $94,900 - $135,600 **Bonus eligible:** No **Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs **Application window anticipated to close:** 01/20/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. FUNCTIONS: Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. EDUCATION: Masters + 2 years of directly related experience. Bachelors + 4 years of directly related experience. Associates + 8 years of directly related experience. PREFERRED QUALIFICATIONS: NPI, Change Control, FATs, Validation, and PPQs. SKILLS: Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams. Enhanced skills in leading, influencing and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. Demonstrate ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Amgen Values/Leadership Practices. Fully bilingual (English/Spanish). WORK METHODOLOGY: Full on site job in Juncos, PR Full time job Expected project duration: 5 months for the first contract, with a high possibility of extension based on performance and budget. Administrative Shift from Monday to Friday. Weekends and overtime may also be required. Professional services contract. Expected hiring date: February 2026

Specialist QA with experience in NPI, Change Control, FAT, Validation and PPQs. RequirementsDoctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experienceBilingual (Spanish/English)(Speak/Write) Technical Writing Computer Literacy

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities. Responsibilities: Review and approve product Master Plans (MPs). Approve process validation protocols and reports for manufacturing processes. Participate in Quality on Incident Triage Team. Approve Environmental Characterization reports. Release sanitary utility systems. Approve planned incidents. Represent QA in the New Product Introduction (NPI) team. Lead investigations and site audits. Own and maintain site quality program procedures. Serve as QA Manager designee on local Change Control Review Board (CCRB). Review and assess risk evaluations. Support automation activities, facilities, and environmental programs. Review and approve Work Orders and EMS/BMS alarms. Approve non-conformance (NC) investigations and CAPA records. Approve change controls Job Requirements: New Product Introduction Change Control FATs Validation, and PPQs Education & Experience: Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.

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: Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. Qualifications: Bachelor's degree in Life Science or Engineering Knowledge and experience in aseptic processes. +4 years of directly related experience Experience with NPI, Change Control, FATs, Validation, and PPQs. Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development. Demonstrate ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills. Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. 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.

Country: United States of America Hybrid U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. Security Clearance: None/Not Required The Global Engineering Center in Puerto Rico is looking for a Software Engineering II professional, with Verification & Validation experience, to join our team. We are looking for a strong, passionate problem-solver with an action-oriented, collaborative mindset who strives to exceed expectations. This person will be in a cross disciplinary team environment and will need to be able to thrive on tackling challenges, as the position requires the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate design or process changes. This position will sit at our Aguadilla, Puerto Rico location. You must be residing in Puerto Rico at the time of starting employment. Relocation is not offered. This role is categorized as hybrid, with 3 days onsite and 2 days remote following the schedule assigned by the Manager. What You Will Do: Measures and analyzes software designs for equipment/products to ensure current and future needs of the business are met. Builds and implements procedures that are used to support hardware and software product development and functions. Operates equipment and computer systems for testing and software design purposes to facilitate operations and ensure that established objectives are achieved. Designs, develops, documents, tests and debugs control and diagnostic systems that contain logical and mathematical solutions. Conducts multidisciplinary research and collaborates with equipment designers in the planning, design, development, and utilization of electronic data processing systems for product and commercial software. Determines end user needs by analyzing system capabilities to resolve problems on program intent, output requirements and input data acquisition. Develops test procedures and code for various UNIX operating systems (Linux & others) and Windows What You Will Learn: You will learn about our growing engineering team in Puerto Rico; What we do. Who we support. How we work. You will learn the technologies of today and tomorrow which we count on to maintain world leadership in the aerospace industry. You will learn why people enjoy and feel fulfilled by working in our industry. Qualifications You Must Have: Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 2 years of prior relevant experience or an Advanced Degree in a related field Experience with software development or, computer/electronic equipment Demonstrated professional experience communicating in English (verbal and written) Qualifications We Prefer: Experience in software development and verification based on DO-178 Experience with Software Lifecycle & Agile software development Experience with HLR/LLR and Requirements decomposition Experience conducting test planning & unit- tests Experience in code review or performance monitoring Knowledge of Python; ADA Experience using C/C++ Experience in National Instruments LABVIEW Experience with communication buses (ARINC-429, ARINC-664, CAN, TTP) Experience with Linux and/or Windows System Administration Experience in Hardware/Software integration and troubleshooting What We Offer: Some of our competitive benefits package includes: Medical, dental, and vision insurance Three weeks of vacation for newly hired employees Generous 401(k) plan that includes employer matching funds Participation in the Employee Scholar Program (ESP) Life insurance and disability coverage Employee Assistance Plan, including up to 8 free counseling sessions. And more! Learn More & Apply Now! Collins Aerospace, an RTX business, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Join our growing engineering team in Puerto Rico, where you will provide critical support to all Collins SBUs, working on exciting programs and projects ranging from the development of the next generation of advanced concept ejection seats to the latest technologies for the U.S. warfighter. WE ARE REDEFINING AEROSPACE. * Please consider the following role type definition as you apply for this role. Hybrid: Employees who are working in Hybrid roles will work regularly both onsite and offsite. Ratio of time working onsite will be determined in partnership with your leader. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

Job Description The QA Associate, Quality Operations is a floor-facing Quality Assurance role that supports day-to-day manufacturing operations in a GMP-regulated environment. This position was opened due to increased team activity and requires strong collaboration with cross-functional partners across Manufacturing, Quality Control, Validation, Engineering, Facilities, and Materials. The role is ideal for an early-career QA professional with hands-on GMP experience who is comfortable working on the production floor and engaging with diverse teams. Key Responsibilities Provide on-the-floor QA support to manufacturing operations, including area clearance, line clearance, and changeover activities to ensure production readiness. Support raw material processes, including review and approval of incoming material documentation and release for GMP use. Review and approve SOPs, Master Batch Records (MBRs), specifications, risk assessments, and other GMP documentation. Generate, revise, and maintain quality-related SOPs and controlled forms. Perform executed batch record review and approval to ensure accuracy, completeness, and compliance. Review and approve deviations, CAPAs, change controls, and associated investigations within the quality management system. Review and approve validation protocols, reports, and protocol executions in alignment with regulatory and site requirements. Review and approve QC laboratory qualification and equipment qualification documentation. Approve work orders in maintenance systems to verify equipment maintenance and calibration compliance. Support inspection readiness activities, partner audits, and regulatory inspections, including document retrieval and subject matter support. Collaborate closely with cross-functional teams to drive continuous improvement and promote a strong quality culture. Technical Skills Experience using quality and enterprise systems such as: SAP (highly used) Veeva Vault (highly used) LIMS (plus) Infor / CMMS systems (nice-to-have) Proficiency in reviewing and managing GMP documentation and quality system records. Requirements Qualifications & Experience Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) required. Minimum of 2 years of professional GMP experience; 2-4 years preferred. Open to candidates with up to ~10 years of experience, provided GMP exposure aligns with the role scope. At least one role with direct, hands-on GMP experience. Experience supporting manufacturing or operational environments required. Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices (GDP). Benefits 9-month contract Administrative shift

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Responsibilities: Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable specifications, materials, tools, techniques, and methodologies. Provides or directs verification and validation of software system requirements, traceability, and testability. Shift: 1st and 2nd Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Preferred Qualifications: Automation/ Controls / Programming hands on experience CAPA/ Investigations/ Root Cause Analyses/Technical Writing Computer Software validations/GAMP knowledge - hands on experience Knowledge in Medical Devices regulations Years' Experience Required: min.7 yrs on field (quality - excluding experience laboratory micro/chemistry ) or engineering or programming Must have: Experience with Risk management documentation: pFMEAs Basic knowledge in PLC, general programming, Source Code Review Basic knowledge in Root Cause Analysis Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) Engineering degree: Mechanical, Electric al or Computer preferred Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) Knowledge in Medical Devices regulations Knowledge in GAMP Skills: Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluations of software systems activities including requirements, design, development, documentation, integration, testing, verification, and validation. Define appropriate measures to ensure product quality. Develop overall operating criteria to ensure implementation of the software quality program in compliance with project, process, and contract requirements. Ensure project and process control documentation meet requirements, objectives, and\/or contracts. Review software systems design, change specifications, and plans against contractual and\/or process requirements. Assess specifications, materials, tools, techniques, and methodologies for compliance. Provide or direct verification and validation of software system requirements, traceability, and testability. Perform other duties as assigned. Requirements Minimum 3 years of field experience in Quality, Engineering, or Programming in the regulated industry. Experience with risk management documentation (pFMEAs). Basic knowledge in PLC, general programming, and source code review. Ability to support CAPA investigations and provide technical writing. Knowledge of designing and reviewing validation strategies (requirements flow down from design to manufacturing). Ability to perform and\/or review process\/equipment validation documentation: URS, FAT, IQ, OQ, PQ, TMV (not laboratory). Familiarity with Medical Device Regulations and GAMP guidelines. Technical Skills (Must Have) Investigation and root cause analysis skills. Technical writing knowledge. Strong organization and communication skills. Process validation and computer software validation knowledge. Ability to use statistical techniques to analyze data. Experience in medical device manufacturing. Interpersonal skills to investigate and collaborate in atypical event investigations. pFMEA development and review. Automated source code management. Computer software programming. Embedded software programming. Development of control plans and PFMEA. Nice to Have Additional experience with investigation and root cause analysis. Top 3 Priorities in Candidate's Experience Automation, controls, and programming hands\-on experience. CAPA, investigations, root cause analysis, and technical writing. Computer software validations and GAMP knowledge (hands\-on). *Willing to work 100% On\-site in Juncos, 1st and 2nd shift.* "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Engineering"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Software Quality Engineer II","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017030019","FontSize":"15","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Responsibilities: * Responsibilities may include the following and other duties may be assigned. * Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. * Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. * Defines appropriate measures to ensure product quality. * Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. * Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. * Reviews software systems design, change specifications, and plans against contractual and/or process requirements. * Reviews include applicable specifications, materials, tools, techniques, and methodologies. * Provides or directs verification and validation of software system requirements, traceability, and testability. Shift: 1st and 2nd Location: Juncos, PR Education: Engineering degree: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Preferred Qualifications: * Automation/ Controls / Programming hands on experience * CAPA/ Investigations/ Root Cause Analyses/Technical Writing * Computer Software validations/GAMP knowledge - hands on experience * Knowledge in Medical Devices regulations * Years' Experience Required: min.7 yrs on field (quality - excluding experience laboratory micro/chemistry ) or engineering or programming Must have: * Experience with Risk management documentation: pFMEAs * Basic knowledge in PLC, general programming, Source Code Review * Basic knowledge in Root Cause Analysis * Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) * Engineering degree: Mechanical, Electric * al or Computer preferred * Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) * Knowledge in Medical Devices regulations * Knowledge in GAMP Skills: * Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . * Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . * May manage large projects or processes that span outside of immediate job area. * Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. * Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. * Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. * Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated Companies Affiliated Companies: Echo Consulting Group Inc

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Quality Professional with Manufacturing Process Audit and Batch Record Review experience. Available for non-standard shifts which include nights and weekends. Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS. Education & Qualifications Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly related experience. (Science and Engineering preferred) Fully Bilingual (Spanish & English) Available for rotating shifts Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group 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.

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services. Job Description Document Control / Data Management Will verify Commissioning, Qualification and Validation Documents as needed. Will Generate data management metrics. Will work with Excel and pivot tables. Administrative and Non Standard Shift. Qualifications Bachelor Degree in Science or Engineering. Not less than 5 years of experience in Pharmaceutical Industry QA experience as CQV reviewer preferred. Excel / pivot tables advanced knowledge is a must. Highly organized. Additional Information More Positions available for Puerto Rico and USA. Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

Responsibilities may include the following and other duties may be assigned: Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures. Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation. Define and implement appropriate measures to ensure product quality. Review software systems design, change specifications, and project plans against contractual and regulatory requirements. Ensure compliance with applicable specifications, tools, techniques, and methodologies. Provide or direct verification and validation of software system requirements, traceability, and testability. Lead and oversee projects from design to implementation, ensuring compliance with policies and industry regulations. Represent the organization as primary contact for projects\/initiatives, communicating with internal and external stakeholders. Provide mentorship, coaching, and training to other professionals within the team. Requirements Experience Minimum 7 years of relevant experience in quality, engineering, or programming (excluding laboratory micro\/chemistry experience). Advanced degree accepted with minimum 5 years of relevant experience. Automation \/ Controls \/ Programming hands\-on experience CAPA, investigations, root cause analysis, and technical writing Computer software validations and GAMP knowledge - hands\-on experience (Additional) Strong knowledge in medical devices regulations Experience with risk management documentation (PFMEAs) Experience designing validation strategies (e.g., requirements flow down from design to manufacturing) Perform and\/or review process validation and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not cleaning or laboratory processes) Knowledge of medical device regulations and GAMP standards Education Bachelor's degree in Engineering (Mechanical, Electrical, or Computer\/Software preferred). Technical Skills Must Have Investigation and root cause analysis skills Technical writing knowledge Strong organizational and communication skills Process validation and computer software validation knowledge Ability to apply statistical techniques to analyze data and develop\/review\/approve test plans and reports Experience in medical devices manufacturing Interpersonal skills to support product disposition investigations (PFMEA, atypical events) Automated source code management Computer software programming (including embedded software programming) Development of control plans and PFMEA Additional Technical Areas (Hands\-On\/Knowledge Required) Programmable Logic Controllers (PLC): Rx Logix configuration & troubleshooting Vision Systems Instrumentation: overview and application Control Systems Data Structure & Sources Data Analysis Tools: SQL, Python, R Data Management Databases: data extraction, transformation, loading, database creation\/maintenance, query overview (SQL\/Non\-SQL) Programming: Assembly (C), Object\-Oriented Programming (Python, Java), error handling, abstract data types GUI\/HMI Design: FactoryTalk, RSView Communication Networks Operating Systems FDA CSA Guidance: knowledge of Computer Software Assurance (CSA) for production and quality system software (FDA Draft Guidance, 2022) Nice to Have Additional investigation and root cause analysis expertise *Willing to work 1st or 2nd shift and 100% on\-Site in Juncos.* "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Aplicar ahora","zsoid":"6314569","FontFamily":"Arial, Helvetica, sans\-serif","job OtherDetails":[{"field Label":"Industry","uitype":2,"value":"Engineering"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Juncos"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Principal Software Quality Engineer","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017078001","FontSize":"15","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}