Quality assurance specialist jobs in Guaynabo, PR - 41 jobs

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.

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence. Position Summary: The Specialist QA will support quality systems and compliance activities in a regulate environment. This role ensures adherence to cGMP, regulatory requirements, and internal quality standards throughout the product lifecycle, including New Product Introduction (NPI), validation, and change control processes. Key Responsibilities: Oversee and execute QA activities related to New Product Introduction (NPI), including review and approval of documentation. Manage Change Control processes to ensure compliance and proper implementation. Support Factory Acceptance Tests (FATs), Process Performance Qualification (PPQ), and validation activities. Review and approve protocols, reports, and other controlled documents. Ensure compliance with FDA, EMA, and other applicable regulatory requirements. Collaborate cross-functionally with Manufacturing, Engineering, and Quality Control teams. Participate in audits and inspections, providing QA expertise and documentation support Education: Doctorate or Master's + 2 years of directly related experience or Bachelor's + 4 years of directly related experience Stand-Out Attributes: Hands-on experience with NPI, Change Control, FATs, Validation, and PPQs. Familiarity with biopharma manufacturing processes and equipment. Experience supporting audits and regulatory inspections. Ability to work in a fast-paced, highly regulated environment. Strong problem-solving and risk assessment skills. This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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: Specialist QA 2100 to 0530 AST (M - F) SUMMARY Perform one or more of the following duties and responsibilities in support of the 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 -Bachelors + 4 years of directly related experience OR COMPETENCIES/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. PREFERRED: 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)

For QA services in the IT and Automation Systems area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Sciences or Engineering with five (5) years in the regulated industry. Bilingual (English & Spanish) Project Management skills Shift: Administrative and according to business needs. Experience in: Design Qualification and Reviews. Revising validation/commissioning, and technical documentation. Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control) and Risk Assessment. Validation (IQ), (OQ), and (PQ) Protocols. Computer Systems Validation (CSV). The Personality Part: Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you're creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we're looking for! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Evaluate relevant documentation compliance such as CR's, SOP's, BR's, BOM's, WPP's, URS, qualification and validation Protocols. Review/Approve equipment/facilities/system validation documents such as System Level Impact Assessment (SLIA), (CCA), (SR), (DQ), (RA), (RAA). Review/approve the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing/laboratory. Review/approve test script and manage revision/approval of any deviations occurring during the project's implementation stage. Review/approve impacted procedures related to process, products, utilities, and laboratories, and ensures compliance of all procedures. Review/approve generated Revalidation Plans. Support risk analysis process when a quality event has happened that cannot be solved immediately. Manage audit observation, investigations, change control and CAPAs records in Infinity System on timely manner. Participate in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings. Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.) WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Responsible for receiving, registering, and forwarding requests for organizational determination and/or any associated clinical documentation or documentation for the clinical management of the insured. Works with the authorizations of services already predetermined through the automatic process using the benefits criteria and in compliance with the applicable organizational determination regulation and universes, reports, and the applicable regulation. ESSENTIAL FUNCTIONS: Receives via facsimile, email, regular mail, or provider portal the requests for pre-service organizational determination and/or any clinical documentation for insured management. Performs Gatekeeper roles according to operational needs to support group leaders in classifying the documentation received and distributing the rest to the technicians. Check the expiration date of faxes in conjunction with the group leader. Manages and analyzes assertively and exhaustively the documentation received, including medical orders, to establish the type of service requested and the level of urgency and ensure that it meets the minimum requirements. Performs the eligibility search and the Pre-authorization requirement of the requested service. Validates information with the provider to complete the process. Documents the pre-authorization in the insured's file, entering the data that complies with the requirements established in reports and/or applicable regulations. Handles complex requests such as services in the US, durable medical equipment, and hospital discharge requiring additional interventions in direct communication with clinical areas to facilitate the process. Performs the authorization of services already predetermined through the automatic process using the benefits criterion in compliance with the applicable regulation, including notification to the insured/provider. Monitors assigned request times to maintain the compliance percentage for both authorizations and area assemblies. Answers the calls received in the unit in compliance with HIPAA regulations and forwards them to the corresponding programs, including calls with complex scenarios such as those in the US requiring intervention and even guidance and assistance. Appropriately handles appeals requests requiring communication and service alliances with the Grievances and Appeals Unit, knowledgeable about the appeal scenarios and the impact on STARS. Works with the queries and requests referred from the Call Center and Service Centers to facilitate the service either by modifying the Pre-authorizations or handling the verbal requests of the insured. Inform the Providers Department of the services that require payment agreement letters for the additional nonparticipating providers. Coordinates the configuration of non-existent providers in the tools. Complies fully and consistently with the Company's standards, policies, and procedures and the local and federal laws applicable to our industry, business, and employment practices. Education and Experience: Associate's Degree and/or sixty to sixty-four (60-64) university credits equivalent to six (6) months to one (1) year of studies in a health-related area. At least one (1) year of related experience. Other: Knowledge of Medical Terminology. CPT and ICD-10 Codes are preferred. Languages: Spanish Intermediate (conversational, writing, and comprehension) English Intermediate (conversational, writing, and comprehension) TPIS is an employer with equal opportunity in employment and take Affirmative Action to Recruit Women, Minorities, Protected Veterans, and Persons with Disabilities.

Expect more. Connect more. Be more at Diebold Nixdorf. Our teams automate, digitize, and transform the way more than 75 million people around the globe bank and shop in this hyper-connected, consumer-centric world. Join us in connecting people to commerce in this vital, rewarding role. Ensures quality and consistency of customer service levels through continual review, feedback and service provider coaching, training and development. Listens in on calls, recordings and / or other customer interactions to evaluate service provider skills in dealing with customers. Verifies / ensures the accuracy and effectiveness of information or advice provided to customers. May act as 'floorwalker' to give immediate assistance to customer service associates regarding customer inquiries. Required Qualifications Bachelor's Degree and equivalent work experience required. Minimum of 2-4 years of relevant experience or equivalent combination of education and experience in Service Quality and Parts Logistics. Good business English and Spanish skills (Written and spoken) Skills Accuracy and Attention to details Customer focus Analytical Thinking Managing Multiple Priorities Quality Management Business Process Management. Data Gathering and Reporting Internal controls Why should you join Diebold Nixdorf? Brightest minds + technology and innovation + business transformation The people of Diebold Nixdorf are 23,000+ teammates of diverse talents and expertise in more than 130 countries, harnessing future technologies to deliver personalized, secure consumer experiences that connect people to commerce. Our culture is fueled by our values of collaboration, decisiveness, urgency, willingness to change, and accountability. -Diebold Nixdorf is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. ** To all recruitment agencies: Diebold Nixdorf does not accept agency resumes. Please do not forward resumes to our jobs alias, Diebold Nixdorf employees or any other organization location. Diebold Nixdorf is not responsible for any fees related to unsolicited resumes** Service Quality Provides Service Quality and Analysis for a specific business function or location Participates in customer service review sessions for various channels (voice, screen capture, email and chat) Analyzes data and generates metrics on quality trends impacting customer satisfaction Provides feedback internally, to DN agents and operations stakeholders on policy adherence, deviations and issues Coordinates with and provides feedback to external quality vendors/ suppliers as required Identifies customer service issues and develops resolution recommendations Provides actionable data to stakeholder groups such as training or process improvement Parts Logistics Gains familiarity with Inventory Control concepts, practices and methodologies Forecasting tasks With Guidance, performs basic Inventory Control duties including: Maintaining Inventory cycle count and physical inventory programs Comparing stock numbers and related information with catalogs, manuals, parts lists and related references Making daily inventory adjustments based on first-hand information Tracking delivery dates and shipment details of purchase orders Ensuring compliance with contractual obligations Assists with special projects as assigned

Expect more. Connect more. Be more at Diebold Nixdorf. Our teams automate, digitize, and transform the way more than 75 million people around the globe bank and shop in this hyper-connected, consumer-centric world. Join us in connecting people to commerce in this vital, rewarding role. Ensures quality and consistency of customer service levels through continual review, feedback and service provider coaching, training and development. Listens in on calls, recordings and / or other customer interactions to evaluate service provider skills in dealing with customers. Verifies / ensures the accuracy and effectiveness of information or advice provided to customers. May act as 'floorwalker' to give immediate assistance to customer service associates regarding customer inquiries.

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: Develops, implements, and maintains an organization's quality management system (QMS), ensuring compliance with standards and regulations through policies, audits, and corrective actions (CAPA). They lead cross-functional teams, manage document control, oversee vendor quality, and use data analysis to drive continuous improvement, ensuring products/services consistently meet customer and company quality goals. Responsibilities: Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Is accountable for overall program process, performance, and customer satisfaction. Shift: 40 hrs usually between 1 and 2 shift (8:30-5:30) Location: Juncos, PR Education: Engineering degree (prefertrable); Sciences Preferred Qualifications: Hands on Experience on Projects/Scheduling for Medical Device manufacturing Excellent Negotiating and Communication Skills Risk Management/Critical Thinking Conflict Resolution skills Knowledge in Medical Devices regulations Skills: Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets . Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management. Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program. Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management. Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. 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

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

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"}

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 Specialist QA with experience in NPI, Change Control, FAT, Validation and PPQs. Qualifications 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 Bilingual (Spanish/English)(Speak/Write) Technical Writing Computer Literacy Additional Information All your information will be kept confidential according to EEO guidelines.

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.

For QA services in the DP Quality Assurance area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in sciences with four (4) years in the regulated industry. Bilingual (English & Spanish) Project Management skills Shift: Administrative and according to business needs. Experience in: New Product Introduction. Change Control FATs, Validation, and PPQs. The Personality Part: Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you're creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we're looking for! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

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. 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. Requirements Minimum 2 years of experience with Investigations and complaints. Work experience with quality system in the pharma industry is acceptable. Bachelor's degree in Science completed. Willing to work 100% on\-site Gurabo. "}}],"is Mobile":false,"iframe":"true","job Type":"Contract","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":"Puerto Rico"},{"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":"118922000016530006","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26rdEozDrUdYhKge.sh YqcHw\-&embedsource=Google","location":"Gurabo","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}

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: Quality Lead is responsible for overseeing all aspects of product quality within the injection molding operations. Develop, implement, and maintain quality systems (ISO 9001, or customer-specific standards). Establish and monitor quality control plans, inspection procedures, and testing protocols. Lead root cause analysis and corrective/preventive actions (CAPA) for nonconformities. Ensures compliance with customer specifications, industry standards, and regulatory requirements while driving continuous improvement initiatives. Establish and inspect quality control processes and audits. Perform inspection of parts and interpret engineering drawings/blueprints. Ensure inspections and documentation comply with GMP and quality standards. Support quality activities during the assigned shift and provide guidance as needed. Qualifications: Bachelor's degree in quality management, or a related field. (Preferred but no required) 3 to 5 years of experience in quality assurance within injection molding or plastics manufacturing. Strong knowledge of ISO standards, Validations, PPAP, FMEA, SPC, and GD&T. Experience with metrology equipment and statistical analysis tools Proficient in the use of measurement tools and verification of their calibration. Strong documentation skills. Leadership abilities. Quality-driven and detail-oriented mindset. Proven knowledge in the use of micrometers, calipers, optical comparators, and basic measuring equipment. Bilingual (English/Spanish) preferred. 1st shift but candidate must be available to work 2nd or 3rd shift if needed. 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.

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: TOP Documentation Specialist The TOP Documentation Specialist is responsible for the collection, review, organization, and delivery of Turnover Packages (TOPs) for all packaging line equipment, systems, and supporting utilities within a GMP-regulated biotechnology site. This role ensures that all engineering, commissioning, qualification, and vendor documents are accurate, complete, and compliant with site standards, FDA/EMA regulations, and project milestones for system handover to Operations and Quality. Key Responsibilities:Turnover Package Management Develop and maintain the TOP index, trackers, and matrix for all packaging lines and supporting systems (e.g., filling, labeling, cartoning, serialization, aggregation, utilities). Coordinate with Engineering, Commissioning (Cx), Validation (CQV), Quality, and Construction teams to ensure all required records are submitted on time. Collect and compile key documents, including: URS, BOD, design drawings, vendor manuals, material certifications, weld maps, FAT/SAT, IQ/OQ/PQ, calibration reports, EHS certifications, and training records. Review all documents for accuracy, revision control, signatures, and GMP compliance before final handover. Compliance & Documentation Control Ensure all TOP documentation complies with GMP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements. Support audit readiness by maintaining organized, retrievable, and secure records (electronic and hard copy). Work with the Quality Unit to ensure final TOP approval and proper archiving into the site's document control system (e.g., Veeva, Documentum, or MasterControl). Project Support & Coordination Act as the central point of contact for document status, gaps, and deadlines for turnover deliverables. Support engineering change controls, redlining of P&IDs/drawings, and transmittal logs as needed. Prepare weekly progress reports on TOP completion percentages and outstanding items for project leadership. Assist in the development of standard templates, workflows, and lessons learned to improve future turnover execution. Qualifications: Required: Associate or Bachelor's degree in Engineering, Technical Sciences, or Document Control/Information Management (or equivalent experience). 3+ years of experience in TOP/document control in a GMP pharmaceutical, biotech, or regulated construction project environment. Strong understanding of GMP documentation, Cx/Qx deliverables, validation protocols, and FDA/EMA compliance. Proficiency with MS Excel/Word, PDF markup, and document control software (Veeva, MasterControl, Documentum, SharePoint). Strong organizational skills with attention to detail, version control, and deadlines. Preferred: Experience supporting packaging line installation and turnover in biotech or pharmaceutical facilities. Familiarity with Kneat or other e-CQV platforms for commissioning/qualification documentation. Knowledge of LEED commissioning and sustainability-related documentation for energy and atmosphere credits. Excellent communication and stakeholder coordination skills. Core Competencies: Attention to Detail & Data Integrity - Ensures every record is audit-ready. Organizational Excellence - Manages large volumes of documents across multiple systems. Collaboration & Communication - Serves as a bridge between engineering, quality, and construction teams. GMP Compliance Focus - Understands the criticality of accurate turnover for regulatory approval and operational readiness.

Provide oversight for the development, implementation, and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies, regulatory requirements, and industry standards. Ensure the performance and quality of services conform to established Quality System standards, agency guidelines, and company expectations. Offer expertise and guidance in interpreting regulatory, governmental, and internal quality policies to maintain compliance across operations. Partner with operating entities to analyze processes, ensure requirement alignment, and drive continuous improvement initiatives. Lead audit and inspection preparation activities; support and coordinate during audits; drive resolution of audit and inspection findings. Act as liaison with internal\/external auditing groups and regulatory inspectors throughout the entire audit lifecycle. Coordinate legal and quality documentation requests in support of government investigations or litigations. Maintain and regularly update quality assurance programs, procedures, and documentation to align with evolving standards and regulatory expectations. Promote uniform global quality standards and facilitate best\-practice sharing across sites and teams. Other duties may be assigned. Requirements Minimum of 4 years of relevant experience in the regulated industry. Top 3 Required Experience Areas: Strong investigation skills with demonstrated root cause analysis capabilities. Proficient technical writing, strong organization, and effective communication skills. Experience in Process Validation and Computer Software Validation (CSV). Bachelor's Degree completed with a minimum of 4 years of relevant experience. Master's degree with a minimum of 2 years of relevant experience. *Willing to work 100% on\-Site in Juncos,PR.* "}}],"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":"Manufacturing"},{"field Label":"City","uitype":1,"value":"Juncos"},{"field Label":"State\/Province","uitype":1,"value":"Puerto Rico"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00777"}],"header Name":"Sr. Quality Systems Specialist","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017233003","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26ksH07zDXwNYrxh4J3I3qZA\-&embedsource=Google","location":"Juncos","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}