Quality assurance specialist jobs in Carolina, PR - 43 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

A proud member of the Elevance Health family of companies, Carelon Global Solutions, formerly Legato Health Technologies is a managed service delivery organization, providing information technology and business operations services for health plans. Performance Quality Analyst I Location: This role requires associates to be in-office 1 - 2 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. When reporting to the office, the location is on Carelon Global Solutions Puerto Rico building located on 654 Ave Munoz Rivera San Juan, Puerto Rico. The candidate must be available to attend on-site during the training period. Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law. Schedule: This position will work an 8-hour shift from 8:00 am - 5:00 pm, Monday through Friday. Additional hours, including weekends or holidays, may be required based on operational needs. The Performance Quality Analyst I is responsible for driving service quality excellence by evaluating the quality of services and interactions provided by organizations within the enterprise. How You Will Make an Impact Primary duties may include, but are not limited to: * Assists higher level auditor/lead on field work as assigned, including performing special audits and targeted audits as requested by internal management. * Participates in pre and post implementation audits of providers, claims processing and payment, benefit coding, member and provider inquiries, enrollment & billing transactions and the corrective action plan process. * Analyzes and interprets data and makes recommendations for change based on judgment and experience, applies audit policy, and assesses risks to minimize our exposure and mitigate those risks. * Documents audit results, documents findings, and suggests appropriate remediation. Minimum Requirements: * Requires a BS/BA; 2+ years related experience in an enrollment and billing, claims and/or customer contact automated environment (preferably in healthcare or insurance sector); or any combination of education and experience, which would provide an equivalent background. Preferred Skills, Capabilities, and Experiences: * Fully Bilingual (English & Spanish), Must be able to write, read and speak both languages in a proficiency level. * Minimum one-year experience in the healthcare industry preferred. * Minimum one-year experience performing audits is strongly preferred. * Minimum one-year experience working with Medicare and Medicaid preferred. Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

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?

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.

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.

Job Description The Quality Assurance Specialist provides quality oversight and support for regulated manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. This role performs QA review, approval, and leadership activities under minimal supervision and serves as a key quality representative across manufacturing, validation, automation, facilities, and New Product Introduction (NPI) initiatives. Key Responsibilities Review and approve Manufacturing Procedures (MPs). Review and approve process validation protocols and reports, including IQ/OQ/PQ and PPQs. Participate as the Quality representative on incident triage teams. Review and approve Environmental Characterization reports. Provide quality release and oversight of sanitary utility systems. Review and approve planned incidents and deviations. Represent Quality Assurance on New Product Introduction (NPI) teams. Lead and approve deviation investigations, nonconformance (NC) investigations, and CAPA records. Lead and participate in site audits and regulatory inspections. Own, maintain, and improve site quality procedures and quality program documentation. Serve as designee for the QA Manager on the Change Control Review Board (CCRB). Review and approve quality risk assessments. Support automation, facilities, and environmental monitoring programs. Review and approve work orders and EMS/BMS alarms. Review and approve change controls in accordance with quality system requirements. Perform lot disposition activities and authorize product release for shipment. Demonstrate and uphold company values and leadership practices. Core Competencies & Skills Strong project management and organizational skills. Ability to independently manage assignments from initiation to completion. Proven experience leading cross-functional teams. Strong influencing, negotiation, and decision-making skills. In-depth knowledge of manufacturing, quality assurance, quality laboratories (QAL), validation, and process development. Experience interacting with regulatory agencies and supporting inspections. Advanced data trending, analysis, and evaluation skills. Ability to assess compliance issues and recommend effective solutions. Strong written and verbal communication, facilitation, and presentation skills. Proficiency with word processing, presentation, database, and spreadsheet applications. Ability to work independently and effectively interact with all organizational levels. Requirements Education & Experience Requirements Doctorate degree; OR Master's degree with 2+ years of directly related experience; OR Bachelor's degree with 4+ years of directly related experience; OR Associate degree with 8+ years of directly related experience; OR High School Diploma or GED with 10+ years of directly related experience. Preferred Qualifications Experience supporting New Product Introduction (NPI) activities. Strong background in Change Control, Validation, Factory Acceptance Testing (FATs), and Process Performance Qualifications (PPQs). Hands-on experience with GMP manufacturing environments. Benefits 6-month contract Administrative Shift

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)

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.

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"}

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?

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

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 standards and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and\/or governmental regulations, and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigation. 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. Other duties may be assigned. Requirements Minimum 4 years of relevant experience within the regulated industry. Experience in Investigation and root cause analysis. Knowledge in Process Validation, Computer System Validation and Technical Writing. Bilingual. Bachelor Degree in Engineering or Science Completed. Willing to work 100% on site and weekend or overtime when needed. "}}],"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":"Juncos"},{"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":"118922000015976001","FontSize":"15","google IndexUrl":"https:\/\/medialgroup.zohorecruit.com\/recruit\/ViewJob.na?digest=QwmVALyT.3IeWOpQAdT26gCial6RtckyxSOPdzrQGXM\-&embedsource=Google","location":"Juncos","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"}