Quality assurance analyst jobs in Puerto Rico

General Summary: Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Duties & Responsibilities: Monitors and tracks all sources of quality detractors utilizing the service database and complaint database. Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations. Develops solutions to database problems of moderate scope and complexity. Writes and assists others in writing standard operating procedures. Generates and identifies significant trends. Regularly reports them to management and appropriate cross functional teams. Provides advanced technical assistance in the use of information mapping technology. Provides support to product review and release functions. Generates moderately complex statistical summaries. Provides support to good manufacturing practice auditing. ​ *Other duties may be assigned. * Requirements Minimum 2 to 4 years of experience in the regulated industry. Experience with Investigations and complaints. Experience with quality system in pharma industry is acceptable. Bachelor Degree completed. Bilingual. Willing to work 100% on\-site in Gurabo. 1st shift (Monday to Friday) "}}],"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":"Pharma\/Biotech\/Clinical Research"},{"field Label":"City","uitype":1,"value":"Gurabo"},{"field Label":"State\/Province","uitype":1,"value":"Gurabo"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00778"}],"header Name":"Analyst 2 \- Quality Assurance","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017132001","FontSize":"15","location":"Gurabo","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

LUMA - Built for Puerto Rico We rely on electricity every day. We need it to run our appliances, power the streetlights and produce the goods and services that drive our economy. At LUMA we are committed to provide Puerto Rico with electricity that we all can depend on. At LUMA, we put people first - our employees, our customers and the communities where we live and work. We encourage and inspire our people to embrace opportunities as they work to build an electricity system that will make Puerto Rico a better place. If you're looking for a career where you can make a tangible difference in the lives of your neighbors and your community, LUMA is the place for you. LUMA offers new jobs designed to respond to the current and future needs of the T&D system. Together we're transforming the island's electric transmission and distribution system, and energizing Puerto Rico. Please note that these new jobs with LUMA offer different terms and conditions of employment to those currently in place with PREPA. We will schedule interviews with all qualified PREPA candidates. All PREPA applicants will receive priority in hiring and a compensation package equal to or better than what they receive today. In order to receive notifications as additional positions and locations are posted, please create a profile on our career site. About the Position This position is within the Regulatory Team. The Regulatory Team works to align LUMA's business plan with the public energy policy goals of Puerto Rico and plays a key role for the design, implementation and reporting on key policy initiatives. Regulatory works with all LUMA departments in support LUMA's compliance and reporting obligations under the Operations and Management Agreement, the energy regulator and other governmental bodies. The team works with multiple external stakeholders and is responsible for the delivery of professional written documents, and verbal reason to support compliance and reporting. The Programs & Performance group within Regulatory works with all LUMA departments setting and controlling LUMA's System Remediation Plan and Performance Metrics set forth the LUMA's Operations and Management Agreement obligations and LUMA's strategic directions. The primary function of this role is to lead, coordinate data gathering, analysis and calculation of business performance index focusing on the Operation & Maintenance (O&M) and regulatory reporting requirements. The individual will be responsible for performing detailed analyses and studies in order to inform LUMA's performance to internal and external stakeholders in the following main areas: System operation, customer service, safety, renewable and energy storage system integration, energy efficiency and demand response. Perform analysis of deviations and root causes analysis of deviations respect to targets. The role includes broad engagement with internal stakeholders, organizations and most relevant data identification to evaluate and calculate performance indexes. Requires expertise in understanding utility business process, data analytical techniques, sensitivity analyses and reporting. What will you get up to everyday? Maintain and Enhance performance index development business process and opened to constant improvement; improve reliability of data analytics and reduce process timing by incorporating data analytic technics and tools Understand utility business process (technical and customer centered) and utility IT systems to coordinate appropriate data gathering. Experience in data outlier identification techniques for data cleansing process before processing them Supervise the calculation of performance index as required by O&M and regulatory requirement across LUMA's functional areas. Evaluate and approve the calculations of monthly (or as required) performance indexes evolution respect to targets. Discuss with appropriate operating area to identify internalities and externalities impacting the index evolution Maintains documentation on processes and ensure data, calculation and study result archiving. Researches and proposes new data sources, methods, and analysis techniques and recommends improvements Identifies causes for indexes errors outside the target range and develops solutions to improve accuracy Clearly and transparently communicates drivers of performance indexes errors and reports variances Follows all policies and procedures. Other duties as assigned. Perform major storm restoration work and associated drills as assigned. Leadership Responsibilities Managing a group of 2+ individuals What We are Hoping You Bring to LUMA LUMA's culture is rooted in the concept of People First, Safety Always. We want your knowledge and expertise to pair with LUMA's globally recognized experts in numerous fields such as customer service, field workforce development, high-voltage transmission engineering, distributed energy resources and mini/micro grid integration. Our employees receive substantial training and development, as well as opportunities for advancement and success. Within our People First, Safety Always culture, we're committed to offering continuous learning opportunities and career-long support for our employees. Education Bachelor's degree in Math, Engineering, Economics, Commerce or Business, or another relevant field. Experience 7+ years related work experience in detailed, multi-variable analytical role. A good understanding of the electric utility model, or other heavily regulated industries, previous experience working at a T&D utility an asset. Demonstrated knowledge and understanding of regulatory principles, statistical analyses, data analyses and performance indices. Organized and able to clearly communicate both verbally and in writing, to cross functional teams. Physical Demands Stationary Position - Constantly Pushing/Pulling/Reaching - Seldom Climb - Seldom Kneel - Seldom Grab - Seldom Bend - Seldom Lift/carry over - 5-10 LBS Vision - 20/20 Corrected Vision Hearing - Receive detailed information if spoken to. Working Conditions Wet or Humid - Seldom Working near or on moving mechanical parts - N/A Working near or on heavy machinery - N/A Working in high places - N/A Exposed to fumes or airborne particles - N/A Exposed to toxic or caustic chemicals - N/A Frequency of working in outdoor weather conditions - Seldom Work with Electricity - N/A Work with explosives - N/A Work on or near a source of radiation - N/A Loud noise conditions (above 87dB)- N/A Other Environmental Factors including weather conditions______________________ We are looking forward to seeing your application! You made it to the end of the job posting! Thank you for expressing interest in LUMA and taking the time to read all the details of this position. We encourage you to apply and give us the opportunity to get to know you better through the recruitment process. Together, we're energizing the people of Puerto Rico. Note: this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, working conditions, physical demands, and activities may change or new ones may be assigned at any time with or without notice. LUMA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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: 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: Ph.D OR MS + 2 years of directly related experience OR BS + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience. Life Sciences or Engineering Skills: Experience performing Quality Oversight Supporting Supply Chain & Incoming operations experience 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.

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.

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 * Bachelors 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 Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. **_Job Summary_** The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities. **_Responsibilities_** + Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers + Load and extract product systematic data on substances within Cardinal Health Master Data systems + Review and evaluate received questionnaire forms for completeness and applicability + Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks + Identify and quantify risk, communicate results effectively to management + Support management of QRA policies governing product quality data + Identify quality and regulatory related issues within current processes, investigate and provide recommendations + Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan. + Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health + Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk + Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains a broad knowledge of the technical disciplines in own functional area; applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise; influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes; in light of culture and diversity **_Qualifications_** + Bachelor's degree preferred + 1-3 years experience preferred + Knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP and California Proposition 65 preferred + Distribution Operations processes (Medical and Pharmaceutical) preferred + Excellent verbal, written, computer, SAP, and interpersonal skills required + Excellent influencing skills + Must be able to multitask and work with competing priorities **_What is expected of you and others at this level_** + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity implications **Anticipated hourly range:** $26.90 per hour - $36.90 per hour **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:** 12/07/2025 *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. Preferred Qualifications: Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (non conformances). 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. Work Methodology: 100% On-site 36 months (1st Contract) 3rd (10:00 pm-6:30 am) and Non- Standard Shift (weekends and overtime may also be required). Professional Service Contract

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The Associate - Quality Assurance supports and provides guidance in deviation investigations, change control proposals, procedures and master formula revisions, validation, and batch disposition. The Associate-Quality Assurance position is essential for maintaining GMP compliance and in the preparation for pre-approval and general inspections by various regulatory agencies. Job Responsibilities: * Support production: review/approve procedures and master formulas. * Provide Quality Assurance oversight to GMP operations. * Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product. * Conduct analytical data review. * Provide coaching and feedback to operational staff. * Participate in and/or lead self-inspection activities. * Performs batch disposition, audit trail reviews, review by exceptions including Delta V interventions. * Maintain relationship with regulatory resources * Contribute to the achievement of key departmental objectives including safety performance, reducing deviations, and training compliance. * Evaluates batch production records. * Ensures documentation is created using good technical writing. * Ensures that deviations are investigated and resolved in a timely manner. * Serves as instructor of GMP and Quality related Standard Operating Procedures (SOP). * Understand the Global Quality Standards (GQS) and Common Quality Practices (CQP) and how they apply to the Process Team operations. * Educate the Process Team and operators on Global Quality Standards (GQS) and Common Quality Practices (CQP). * Understand the science behind the process and equipment to facilitate science-based decision making. * Know how upstream/downstream processing is affected by their process steps. * Know the Operational Control Strategy and potential failure modes of the process. * Know the historical deviations/gaps, trends, and audit history of the process. * Perform classification, review and approval of observations and changes. * Use statistical data to understand the sources of variability and to continuously improve the process. * Review that practice matches procedure on the production floor. * Ensure the Quality Systems complies with the Quality Standards. * Serve as a liaison between the Process Team and other Quality areas (Laboratories, Compliance, Incoming, etc.). * Review and approve deviations assuring robustness of Root Cause Analysis and effectiveness of Corrective Actions/Preventive Actions (CAPA). Assist in regulatory inspections. * Escalate quality issues from manufacturing to the site-based process team. * Notifies and escalate to quality management significant quality or compliance related issues. * Provide visibility on metrics related to change controls and deviations and any other quality key performance indicator as needed. Process Optimization & Continuous Improvement * Review, identify, and drive alignment of Quality Assurance systems across the supported operation. * Review and identify opportunities for continuous improvement and Simplification and assist in prioritization of opportunities with respect to overall business objectives. * Collaborate with key support groups around the development of process knowledge and a common process improvement agenda. * Serve as liaison between Frontline Associate Quality and key Lilly affiliates quality personnel, Global Quality Unit during the consultation of Quality and Regulatory policies (e.g., Global Quality Standard (GQS), Lilly Quality Practices (LQP), Food and Drug Administration (FDA), and European Medicine Agency (EMA) Regulations). * Serve as liaison between Quality Assurance and other functional areas that support the Process Team (e.g., Laboratories, Engineering, Supply Chain, Planning, Safety, CCI, Production, Automation, TS/MS, FUME) * Benchmark Quality systems, process efficiency, and effectiveness. Basic Requirements: * Bachelor's degree in Chemistry, Microbiology, Biotechnology or Science, preferred. PharmD professionals are encouraged to apply. * Puerto Rico pharmacist license from the Department of Health (preferred). * At least three (3) years of experience in Production, Quality Control, Quality Assurance, Technical Services, Regulatory is desirable. * Knowledge of FDA cGMP's and other regulatory requirements * Fully bilingual (English/Spanish) * Effective communication skills (both verbal and written) * Technical Writing in English and Spanish. * Good interpersonal and teamwork skills * Organize and prioritize multi-functional tasks * Attention to details and ability to identify improvement opportunities or discrepancies. * Strong compliance mindset and sound judgement * Demonstrated decision-making, problem-solving, organizational, and critical thinking techniques. * Knowledge of pharma/biotechnology operations and related sciences. Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $52,500 - $77,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website ************************ to learn more about our services and solutions! Job Description We are seeking a highly skilled and detail-oriented Specialist QA to support supply chain operations within a pharmaceutical environment. This role focuses on ensuring compliance and quality oversight across incoming material inspection, warehouse floor audits, and deviation management. The ideal candidate will bring technical expertise, digital fluency, and a strong understanding of regulated environments. Primary Focus Areas • Perform sampling and inspection of incoming materials and components. • Conduct quality audits of warehouse floor operations to ensure compliance with SOPs and GMP standards. • Initiate, investigate, and approve quality deviations (non-conformances) in coordination with cross-functional teams. • Utilize Smartsheet, Power BI, SAP, and Generative AI tools to manage quality data, reporting, and workflows. Additional Responsibilities • Review and approve Master Production Records (MPs) and process validation protocols/reports. • Represent QA on New Product Introduction (NPI) teams and incident triage groups. • Approve Environmental Characterization reports and release sanitary utility systems. • Lead investigations and site audits; own site-level quality program procedures. • Act as designer for QA Manager on local Change Control Review Board (CCRB). • Review risk assessments, work orders, EMS/BMS alarms, and planned incidents. • Approve NC investigations, CAPA records, and change controls. • Provide lot disposition and authorize product lots for shipment. • Support automation, facilities, and environmental compliance programs. Qualifications Education in a relevant scientific or engineering discipline: -Doctorate or Masters + 2 years of directly related experience or -Bachelors + 4 years of directly related experience Shift - Available for 3rd shit and Non-Standard Shift. Additional Information All your information will be kept confidential according to EEO guidelines.

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: Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. 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. Shift: 3rd Shift/Non-Standard Shift Location: Juncos, PR Education: Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. Preferred Qualifications: Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (non-conformances) 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 Values/Leadership Practices. 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

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Requirements: Supply Chain Incoming sampling and inspection Quality audit of warehouse floor operations Proficient in Smartsheet, Generative AI, Power BI, SAP Initiating and approving Quality deviations (nonconformances) 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. Education: Doctorate or master's and 2 years of directly related experience; bachelor's and 4 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: 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, changes 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. Qualifications: Bachelor's degree in Engineering: Mechanical, Electrical or Computer/Software preferred (not Science) or Programming Minimum of 7 years of experience on field (quality - excluding experience laboratory micro/chemistry) or engineering or programming Experience with Risk management documentation: pFMEAs Basic knowledge in PLC, general programming, Source Code Review (e.g. Automation/ Controls / Programming hands on experience) Computer Software validations/GAMP knowledge - hands on experience Basic knowledge in Root Cause Analysis CAPA/ Investigations/ Root Cause Analyses/Technical Writing Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing) 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 Shift: 1st and 2nd shift and weekends (it will depend on production schedule - projects will be executed at different time shifts; sometimes on weekends. 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.

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.

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 (***************************************************************************************************************************

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. Experience Requirements: 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 Requirement: 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 Work Methodology: Full time contract 100% on-site job in Medtronic- Juncos, PR First contract until August 2026 based to performance and budget availability. Willing to work 1st or 2nd shift

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"}

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 ( 1st & 2nd Shift)","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"}