Quality assurance specialist jobs in Bayamn, PR

**Req number:** R6830 **Employment type:** Full time **Worksite flexibility:** Remote **Who we are** CAI is a global technology services firm with over 8,500 associates worldwide and a yearly revenue of $1 billion+. We have over 40 years of excellence in uniting talent and technology to power the possible for our clients, colleagues, and communities. As a privately held company, we have the freedom and focus to do what is right-whatever it takes. Our tailor-made solutions create lasting results across the public and commercial sectors, and we are trailblazers in bringing neurodiversity to the enterprise. **Job Summary** We are looking for a motivated Documentation Specialist ready to take us to the next level! If you have the ability to schedule meetings, gather meeting topics, and prepare agendas and are looking for your next career move, apply now. **Job Description** We are looking for a **Documentation Specialist** to support implementations encompassed in a modernization effort by scheduling meetings, preparing agendas and taking notes during these meetings. This position will be **full-time contract** and **remote** . **What You'll Do** + Schedule meetings, gather meeting topics, and prepare agendas + Make copies, take notes during project meetings, document, and track action items + Assist project management staff with documentation and load documents to appropriate SharePoint sites + Perform other related activities necessary to meet project goals and objectives + Collaborate as part of a team with two (2) full-time dedicated scribes working directly with Project Managers for the duration of the projects **What You'll Need** Required: + 2+ years of experience capturing and distributing meeting minutes, documenting, and tracking action items Preferred: + Experience supporting IT system modernizations + Experience with Microsoft 365 and ALM solutions **Physical Demands** + Ability to safely and successfully perform the essential job functions consistent with the ADA and other federal, state, and local standards + Sedentary work that involves sitting or remaining stationary most of the time with occasional need to move around the office to attend meetings, etc. + Ability to conduct repetitive tasks on a computer, utilizing a mouse, keyboard, and monitor **Reasonable accommodation statement** If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employment selection process, please direct your inquiries to application.accommodations@cai.io or (888) 824 - 8111. $32.00 - $36.00 per hour The pay range for this position is listed above. Exact compensation may vary based on several factors, including location, experience, and education. Benefit packages include medical, dental, and vision insurance, as well as 401k retirement account access. Employees in this role may also be entitled to paid sick leave and/or other paid time off as provided by applicable law.

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.

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.

What's the role? As the Fiber Documentation Specialist, you will lead the documentation of physical fiber paths across the Liberty network. In this position, you will be working in the Fiber Operations Team and also closely partnering with Fiber Planning, Outside Plant, Operations, Design, Construction and Engineering. The position is required to handle posting and supervising critical business deliveries in the management of the inventory of fiber networks, routes, fiber enclosures, fiber optic cable, conduit, location data, among others. How do you add value? * Use of ArcGIS, ArcFM different solutions, Google Earth Pro & Microsoft Vizio to detail routes for underground and aerial fiber optic cable in private and public right of ways for desktop reviews * Lead the conversion of source data into drawings (e.g., CAD/PDF/Shape/KML/KMZ files) showing placement of existing & new fiber optic cable. * Ensure fiber optic database is current and accurate by inputting data regarding location of fibers and fiber enclosures into the Fiber Inventory data management system. * Participate in design and review of new Fiber Mapping improvements and integrations. * Effectively interface and optimally connect with Management and colleagues in Engineering, OSP, Third Party Engineering & Construction crews, Project Management, Network Engineering, B2B operations, and vendors, among others. * Build simple ad-hoc or presentation-quality maps, depending on the situation, for engineers, account executives and peers. * Prepare information in various formats (e.g., maps, spreadsheets, slides) for field operations, and network operations as the need arises. * Prioritize workday efficiently to improve efficiency by utilizing accurate time management techniques. * Balance priorities with consideration for importance and vitality of projects. Quickly switch between numerous small projects, requiring immediate response, and larger projects having multiple steps and longer deadlines. * Provide inputs in support of optical platform troubleshooting, including measured and/or predicted distances and losses across the optical spectrum vital. * Develop and maintain process layouts, specifications, data sheets, procedures, and quality inspections for the department. * Serve as a consultant for special projects. * Assist in the accomplishment of company objectives by performing other related duties as assigned. * Demonstrate and ensure compliance with the Customer First Philosophy, all Liberty Latin America's policies and procedures including the Code of Conduct and Liberty safety standards and procedures. * Other functions may be assigned. What do you need? Education and/or Experience BBA in Engineering, Computer Programming, or related field. 2-3 years related experience in Telecom industry. Required Skills and Qualifications: * Needs to have validated understanding of telecom, more specifically fiber networking. * Must have a proficient and proven understanding of GIS. * Must be proficient on the understanding of Microsoft Office products, as well as Google Drive. * Able to think critically and analytically and work in a team environment. * Attention to detail and quick learner. * The environment we work in is consistently changing from day to day so you must be adaptable to a quickly changing environment. * Ability to multitask efficiently and work within a timeline when needed. * Knowledge in Telecommunication tools to do in-depth research and ability to use platforms for fiber documentation. * Will support current Fiber team, this includes being assigned random tasks. * Meets and aligns with all Liberty safety's practices and industry standard practices. * Ability to work with and interpret results from optical test equipment, including power meters, OTDRs, or optical spectrum analyzers. * Ability to use AutoCAD, Bentley Micro station, or equivalent software. * Understanding of optical transceivers with ability to interpret part numbers. * Understanding of amplification and dispersion compensation principles at 10Gbps and greater data transmission. * Strong understanding of fixed, mobile, and converged Telecommunication networks. Liberty Puerto Rico provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, citizenship, age, marital status, social status, sexual orientation, gender identity, protected veteran, military service obligation, disability status, genetic information, political affiliation, and being or being perceived as a victim of domestic violence, sexual assault, or stalking. In addition to federal law requirements, Liberty aligns with applicable local laws governing nondiscrimination in employment in every location in which the company has facilities. 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. Assessment, background check and drug test will be required to be a successful candidate. If you believe you have been discriminated against you may notify the Equal Employment Opportunity Commission, the Federal Communications Commission, or other appropriate agency.

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. Organization Overview: The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing. As part of the role will support project implementation for the site in all phases ensuring compliance with requirements and regulations. Support and oversight as Quality Unit for qualifications and all related documentation. Responsibilities: Ensure compliance with Good Manufacturing Practices (GMPs) and corporate quality policies with special attention to the following elements: • Participating in qualification strategies, change control evaluations, deviation assessments, periodic quality evaluations, procedure management, and documentation retention • Fulfill individual training plans, act as a quality procedure instructor and mentor, actively participate in Flow Team activities, and attend departmental meetings • Monitoring pest control and facility maintenance, supporting Lean implementation, evaluating validations and changes related to utilities, equipment, and facilities, and ensuring regulatory plan approvals • Ensures compliance with data integrity per 21 CFR Part 11, computerized system validation policies, and handles controlled substances according to legal and company requirements, including reporting deviations and illicit activities Basic Requirements: Bachelor's degree in Engineering (Chemical, Electrical or Mechanical) Minimum of 3 years of experience in facilities, equipment, utilities and FDA regulated environment. PE or EIT, preferred Additional Skills/Preferences: Bilingual (English/Spanish) with strong written and oral communication skills Strong leadership and organizational skills Sound judgment Teamwork oriented; ability to work cross functionally Able to manage multiple project objectives or assignments Strong customer service focus Additional Information: Able to work extended hours as applicable to support business needs Located at Carolina, PR This position is not permanent. It is for a fixed term position up to a maximum of 1 year. 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 - $154,000 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

The Advisor, Regulatory Compliance is responsible for providing support in the development, maintenance, and monitoring of the Compliance Management System, focused primarily on federal and local consumer protection laws and regulations for Financial Institutions in the banking business. Position will be working hybrid based in San Juan, PR. Main Duties & Responsibilities * Achieve the overall compliance annual plan objectives. * Develop and facilitate consumer protection laws and regulations training materials, as needed. * Participate in the consumer compliance annual risk assessment exercise. * Support Management in the revision of the compliance policies and procedures. * Provide regulatory advice on marketing material, strategies and implementation plans for new products or services. * Respond to requests for advice, review and approve marketing materials, advertisement, and contest rules, and assist with any other special project as required by the Regulatory Compliance Unit Manager. * Maintain management informed of new laws and regulations, and/or changes thereof. * Serve as advisor and project manager for implementing new or amended regulatory requirements, including procedures' review and providing training to business units, as needed that may arise about consumer protection laws and regulations. * Advice business units and Management regarding consumer compliance regulatory matters. * Other duties may be assigned. Minimum Requirements * Bachelor's degree in Business Administration, Accounting or Finance required. JD preferred. * Three (3) years of experience in compliance, risk or any other related area required. Banking experience preferred. * Certified Regulatory Compliance Manager (CRCM) certification preferred. * The minimum education and experience required can be substituted with the equivalent combination of education, training and experience that provides the required knowledge skills and abilities. * Extensive knowledge of financial institution policies and procedures required. * Experience in project management and implementation preferred. * Ability to read, analyze, and interpret federal and local consumer protection laws and regulations. * Analytical, proactive problem solving, organized, detail oriented and able to multitask observing the defined quality standards. * Effective and clear communication skills with a broad range of employees across the organization. * Innovation and flexibility for meeting the demands of an ever-changing market. * Excellent computer skills, including Microsoft Office (Word, Excel, Power Point). * Excellent interpersonal skills, and ability to work effectively with internal clients. * Excellent written and verbal communication skills in Spanish & English required. WORK AUTHORIZATION & ELEGIBILITY: * Legally authorized to work in the US is required. This position is of indefinite duration and requires candidates to have permanent or ongoing work authorization. * Employee is responsible for maintaining eligible work authorization throughout his tenure with the organization. Oriental is an Equal Opportunity Employer (EEO/Affirmative Action for Veterans/Workers with Disabilities) Recruitment Privacy Statement Compliance Posters #LI-Hybrid

**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. **MANAGER QA - DRUG SUBSTANCE OPS (NIGHT SHIFT)** **What you will do** Let's do this. Let's change the world! In this vital role in support to Amgen's Quality Assurance program, we are seeking a highly motivated and proactive leader to join us as Manager QA, to lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation (night shift). **Specific responsibilities include but are not limited to:** + Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management. + Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations. + Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards. + Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays. + Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents. + Represent QA in New Product Introduction (NPI) teams and during audits and inspections. + Lead investigations and plant audits; approve change-over completion activities. + Ensure deviations are properly investigated and documented; verify accuracy and completeness of production records and test results. + Collaborate cross-functionally to ensure QMS processes follow established procedures. + Bring up quality, compliance, supply, and safety risks to senior management. + Ensure controlled documents have assigned owners and that periodic reviews are completed on time. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The Manager QA professional we seek is a strong leader with these qualifications. **Basic Qualifications:** Doctorate degree Or Master's degree and 3 years of experience in regulated industry experience Or Bachelor's degree and 5 years of experience in regulated industry experience Or Associate's degree and 10 years of experience in regulated industry experience Or High school diploma / GED and 12 years of experience in regulated industry experience In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above **Preferred Qualifications:** + Educational background in Life Sciences or Engineering + Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development. + Validated expertise in Quality Systems such as Deviations, CAPA and Change Control + Experience leading cross functional teams with the influencing and negotiating skills + Strong organizational, project management and change management skills + Strong communication skills (both written and oral), and comprehend in English and Spanish + Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads. + Ability to interact with regulatory agencies **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans and an annual site shutdown + Flexible work models, including remote work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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"}

For Engineer services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Life Sciences and over eight (8) years of exposure within the Pharmaceutical & Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Excellent Communication skills, and Positive attitude. Shift: 1st Shift Experience in: Quality Systems, including CAPA, Change Control, and Validations Medical Device Regulatory Requirements and compliance standards Quality and Regulatory Audit activities, including preparation, execution, and follow-up The Personality Part: Our Next Piece is someone who leads with empathy, communicates with clarity, and thrives in complex, collaborative environments. They coach others, solve problems creatively, and make a meaningful impact through trust and initiative. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Work directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet guidelines. Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all stages. Coordinate legal requests in support of government investigations or litigations. Ensure the quality assurance programs and policies are maintained and modified regularly. Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves on 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?

GENERAL DESCRIPTION: Coordinates appointments and services, and supports all initiatives related to quality documents. Provides support to the entire Quality Department by preparing documents and reviewing information to comply with the different regulations and policies and procedures. ESSENTIAL FUNCTIONS: Performs data entry, and review of documents, formats, forms, and/or information related to the Department. Coordinates and ensures constant and effective communication with other company departments for the intervention and/or requests for information required to support the completion of projects and/or activities related to the department, according to operational need. Coordinates the planning of the Quality Department's meetings as required. Keeps track of standards, documentation, binders, and applications in preparation for audits and Administrative Quality processes. Maintains the supervisor informed of the status of tasks related to Quality projects to keep them notified of the progress of these projects. Supports different administrative tasks related to the Model of Care, AAAHC accreditation and other projects, as needed. Performs presentations for the Administrative Quality initiatives as required. Digitalize documents and different information in the corresponding Administrative Quality folders. Keeps electronic files organized and in the required formats to present and use as reference as required. Maintains records, documentation, and folders for each project, request, and/or special event to be used as reference. Receives, answers, and effectively forwards calls and/or requests received in the department and monitors for resolution in cases that merit it. Supports the submission of reports required by regulatory agencies promptly and as requested (ASES, CMS, Other Departments) among others. Validates and determines the procedures to be conducted to refer requests to the corresponding areas, maintains a record of said procedures, and provides follow-up. ADDITIONAL FUNCTIONS: Must comply fully and consistently with all company policies and procedures, with local and federal laws as well as with the regulations applicable to our Industry, to maintain appropriate business and employment practices. May carry out other duties and responsibilities as assigned, according to the requirements of education and experience contained in this document. MINIMUM QUALIFICIATIONS: Education and Experience: Associate's degree, preferably in Business Administration, Management, Accounting, or related areas. At least one (1) year of experience performing administrative and coordination tasks. "Proven experience may be replaced by previously established requirements." Certifications / Licenses: N/A Other: N/A Languages: Spanish-Advanced (writing, reading, and conversational) English-Advanced (writing, reading, and conversational) Job Type: Full-time Salary: From $13.00 per hour Expected hours: 38.5 per week Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

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: Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Responsibilities: Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies. Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements. Shift: Administrative Location: Juncos, PR Education: 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. Preferred Qualifications: Scientific Data Analysis Strong Technical Writing (English and Spanish) mainly focuses Strong knowledge in Microsoft Excel as a Tool for Data Analysis Good Communication skills Project Management Knowledge in Computer System and Method Validation (Experience preferable) Strong knowledge and experience with quality process management Basic Knowledge on equipment preventive maintenance and troubleshooting Agile on prioritization of critical tasks Ability to develop inspection or qualification protocols in a short timeframe period. Strong negotiation skills Skill: Understand, support and demonstrate the values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills. Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution. Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes. Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products. Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating. 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

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.

Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. MANAGER QA - DRUG SUBSTANCE OPS (NIGHT SHIFT) What you will do Let's do this. Let's change the world! In this vital role in support to Amgen's Quality Assurance program, we are seeking a highly motivated and proactive leader to join us as Manager QA, to lead and oversee the activities of the plant Quality Assurance department in our multi-product mammalian cell culture facility located in Juncos, Puerto Rico in a non-standard shift operation (night shift). Specific responsibilities include but are not limited to: Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management. Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations. Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards. Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays. Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents. Represent QA in New Product Introduction (NPI) teams and during audits and inspections. Lead investigations and plant audits; approve change-over completion activities. Ensure deviations are properly investigated and documented; verify accuracy and completeness of production records and test results. Collaborate cross-functionally to ensure QMS processes follow established procedures. Bring up quality, compliance, supply, and safety risks to senior management. Ensure controlled documents have assigned owners and that periodic reviews are completed on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Manager QA professional we seek is a strong leader with these qualifications. Basic Qualifications: Doctorate degree Or Master's degree and 3 years of experience in regulated industry experience Or Bachelor's degree and 5 years of experience in regulated industry experience Or Associate's degree and 10 years of experience in regulated industry experience Or High school diploma / GED and 12 years of experience in regulated industry experience In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Educational background in Life Sciences or Engineering Experience with processes involved with Quality Assurance, manufacturing and distribution, Quality Control, validation, and process development. Validated expertise in Quality Systems such as Deviations, CAPA and Change Control Experience leading cross functional teams with the influencing and negotiating skills Strong organizational, project management and change management skills Strong communication skills (both written and oral), and comprehend in English and Spanish Ability to provide direction and establish goals for individual staff members and work groups, empower staff, manage and distribute workloads. Ability to interact with regulatory agencies What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and an annual site shutdown Flexible work models, including remote work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

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"}

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. Responsibilities: Responsibilities may include the following and other duties may be assigned. Develops, implements, administers and certifies compliance policies, procedures, and practices. Ensures alignment with legal and ethical standards of the organization. Provides compliance advice, investigates complaints and verifies deficiencies are corrected. Develops employee communication and training programs that focus on the elements of a companywide compliance program. Enforces antibribery and anticompetition laws. Analyzes metrics and audits functional compliance program. Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program. Shift: 1st Location: Juncos, PR Education: BS Science or Engineering Preferred Qualifications: 8+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry. Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability Skills: Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. 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 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"}