Quality technician jobs in Puerto Rico

Title: Quality Control Specialist (3500410) Work Model: 100% Onsite - Administrative Shift Positions: 1 Contract: Approximately 7 months, by contract with ProQuality Network Summary Our client is seeking a highly skilled Quality Control Specialist to serve as a technical expert in molecular biology and microbiology testing and development. This role focuses on complex technical issues with multi-site, multi-organizational, and external resource impact. Preferred Qualifications A strong scientific or engineering background is preferred, including experience in the pharmaceutical industry, Quality Control, laboratory testing, and quality processes. Relevant backgrounds may include Microbiology, Chemistry, Biochemistry, Molecular Sciences, or Chemical Engineering. Scientific data analysis proficiency Strong technical writing skills (English and Spanish) Advanced knowledge of Microsoft Excel for data analysis Excellent communication skills Project management capabilities Knowledge of computer systems and method validation (preferred) Experience with quality process management Basic knowledge of equipment preventive maintenance and troubleshooting Ability to prioritize critical tasks effectively Capability to develop inspection or qualification protocols within short timelines Strong negotiation and interpersonal skills Functions Provide technical guidance, generate reports, perform data analysis, and ensure clear communication across technical groups. Resolve technical issues and troubleshoot assays as needed. Ensure laboratory compliance by implementing and maintaining GMP, GLP, and safety standards. Manage or develop new programs, processes, and methodologies. Develop, revise, and audit complex controlled documents with multi-site or multi-organizational impact. Approve laboratory investigations and lead internal audit teams. Serve as a subject matter expert for technical training as needed. Perform routine testing or responsibilities within assigned areas. Represent the department on cross-functional or multi-site teams and complete assigned action items independently. Interact with regulatory agencies, including preparation of written responses. Coordinate with external resources to resolve technical issues. Execute special projects as assigned by the supervisor. Supervise team members as necessary to meet technical or project requirements. Education Requirements Doctorate, OR Master's degree + 2 years of directly related experience, OR Bachelor's degree + 4 years of directly related experience, OR Associate degree + 8 years of directly related experience, OR High school/GED + 10 years of directly related experience. Competencies / Skills Demonstrated support and alignment with organizational values. Excellent communication, facilitation, and presentation skills. Strong technical writing capabilities. Advanced proficiency in computer applications, including databases, presentations, and spreadsheets. Exceptional project management and organizational skills. Ability to independently interpret and execute complex instructions. Strong multitasking abilities with flexibility to shift priorities as needed. Extensive experience in analytical laboratory processes, validation, manufacturing, quality assurance, process development, and distribution. Deep understanding of pharmaceutical testing, assay development, and validation. Knowledge of pharmaceutical and biological manufacturing processes. Strong understanding of U.S. and basic international regulations for pharmaceutical/biological product testing. Extensive knowledge and application of GMPs/CFRs. Ability to assess and document compliance issues. Proficiency in equipment maintenance, troubleshooting, and operation within area of expertise. Advanced scientific data analysis, interpretation, trending, and problem-solving skills. Strong independent work ethic and ability to collaborate effectively at all organizational levels. Ability to communicate effectively with regulatory agencies (oral and written). Ability to initiate, coordinate, and lead cross-functional teams. Strong leadership, motivation, influence, and negotiation skills. If you meet these qualifications and are interested in joining our client's team, we invite you to apply using the job description link provided.

TITLE: Service & Quality Coordinator REPORTS TO: Unit Director STATUS: o Full time - Hourly ü Full time - Salary o Part Time - Hourly CLASIFICATION (FLSA): üExempt o Non-Exempt GENERAL DESCRIPTION: Responsible for registering the attendance of the participants daily, keeping the data updated in the system, and monitoring compliance with the proposals that subsidize the operations. It establishes strategies to guarantee the retention of the participants and offers suggestions to the leaders of Health and Life Skills, education, Recreation and Sports, Youth Development, Career Development, and Employability among others on the effectiveness, quality, and efficiency of the programs. TASKS AND DETAILED WORK ACTIVITIES: Keeps the membership system up to date with the correct and updated data. Enroll all participants and maintain a record of all required documents. Guides all participants on the important aspects and benefits of the club and guarantees that they use the membership card. Evaluate the frequency of the participants' attendance, identify trends and analyze the results to ensure that the Unit is meeting the requirements of the proposals. Make the required reports on time and with accurate information. In addition, it offers suggestions and proposes strategies to support the programs. Ensures security, promotes a risk-free environment, and maintains the proper appearance of the reception area. Supports the Unit Director Leader in analyzing the effectiveness of the club and the operation in general. Coordinate activities in the community to market the club and in turn meet the required attendance of participants, as well as retention and impact on other youth. Communicate and distribute information about upcoming events and activities. Develops solidarity with other Clubs and other non-profit organizations to establish links with professionals in the community; visits program participants' schools at least once per semester. In addition, it will establish and promote alliances with the schools of the participants. Promote customer service in your area and throughout the Club and is a positive example inside and outside it. Identify and manage possible risk situations for the Unit's operations. Know and serve the clientele of donors, participants, families, and communities. Oversees and evaluates the performance of the Maintenance Leaders and Safety Leaders to ensure compliance with action and work plans. Perform any other task requested by the supervisor. SUPERVISORY RESPONSIBILITIES: Determine schedules, sequences, and assignments for work activities, based on work priority and skill of personnel. Provide guidance and direction to subordinates, including setting performance standards and monitoring performance. Encouraging and building mutual trust, respect, and cooperation among team members. Identify the developmental needs of others, developing formal educational or training initiatives, such as, coaching, mentoring, or otherwise helping others to improve their knowledge or skills. Confer with personnel, to coordinate work activities, resolve employee grievances, or identify and review resources needed. Inspect and monitor work areas, examine tools and equipment, and provide employee safety training to prevent, detect, and correct unsafe conditions or violations of procedures and safety rules Recommend or initiate personnel actions, such as hires, promotions, transfers, discharges, or disciplinary measures. EXPERIENCE, EDUCATION, SKILLS & KNOWLEDGE REQUIRED: Bachelor of Business Administration from an accredited university and one (1) year of related experience. Grade Associate of Business Administration, Computer Information System or Office System from an accredited university and one (1) year of related experience. Administrative - Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology. English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. Personnel and Human Resources - Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems. Communicating with Supervisors, Peers, or Subordinates - providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. Coordinating the Work and Activities of Others - getting members of a group to work together to accomplish tasks. Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems Making Decisions and Solving Problems - analyzing information and evaluating results to choose the best solution and solve problems. Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards. Data or Information Analysis - Identifying the underlying principles, reasons, or facts of information by breaking down the information or data into separate parts. Monitor Processes, Materials, or Surroundings - monitoring and reviewing information from materials, events, or the environment, to detect or assess problems. Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making. PHYSICAL REQUIREMENTS & WORK ENVIRONMENT: Individuals may need to sit or stand as needed. The position may require walking primarily on a level surface for periodic periods throughout the day. May reach above shoulder height or below the waist and lift as required to file documents or store materials throughout the workday must be able to lift 15 pounds and use proper lifting techniques. Works in a dynamic environment with children and young people, which can vary as necessary. It is continually transported from one place to another. Standing or sitting and speaking or listening are regularly required. Ability to use common office equipment such as computers, facsimiles, printers, calculators, etc. You are frequently required to drive motor vehicles. DISCLAIMER: The information presented indicates the general nature and level of work expected of employees in this classification. It is not designed to contain, nor to be interpreted as, a comprehensive inventory of all duties, responsibilities, qualifications, and objectives required of employees assigned to this job. An Equal Employment Opportunity Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Quality Support Team Inspector Organization: Lufthansa Technik Puerto Rico (LTPR) Department: Quality Responsible to ensure maintenance standards are secured through aircraft close, final, Defect buybacks, and RII inspections. Ensures maintenance standards are improved by identifying and suggesting improvement opportunities Essential Responsibilities Ensure progress is made on the aircraft in line with the project network plan and given targets. Perform close, Final, Defect Buyback, and RII inspections. Develop an inspection schedule with team leaders, Project Manager, and customer during inspection phase. Perform surveillance activities using customer's and LTPR's checklists. Record inspection findings and surveillance activities. Analyze inspection findings and propose continuous improvement initiatives and training. Assist or perform Aircraft CRS Perform in-process inspection on aircraft undergoing repair, overhaul, or alteration to assure compliance with specifications and procedures and with accepted quality standards and practices. Accomplishes final inspections on aircraft to confirm the completeness of the work done is aligned with manufacturer specification. Ensure all work Performed by Production or required to be performed have been signed for and no defect exist that would render the aircraft unairworthy Performed inspection on component changes, test and adjustment on airframe and powerplant systems consistent with good quality practices and to the requirements of the appropriate Aircraft Maintenance Manual Perform inspection on structural repairs and modifications to ensure compliance to good quality practice and to the requirements of the manufacturer Structural Repair Manual (SRM) or any other approve data. Performs Surveillance inspections and Spot Check. Document noted discrepancies on company control forms and follow-up to ensure all the noted anomalies have been corrected. Records/documents discrepancies and conditions or operation malfunctions for correction, adjustment, or repair; evaluates defects and prescribe corrective actions on any discrepancies discovered during inspection. Complete Service Difficulty Report (SDR) for any major incident Complete 337 Report for customers and the Federal Aviation Administration (FAA) Other Responsibilities Maintains working area clean and organized. Comply and ensure compliance with company policies, procedures, local and federal regulations. Perform other tasks and projects, as requested. Ensure adherence to compliance culture requirements. Education, Skills, and Competencies Technical university degree in aviation A&P Certificate License Minimum 3 years' experience in commercial aircraft maintenance of which minimum 18 months A320 family experience A320 family 80-hour General Familiarization course desired Involvement in aircraft maintenance for at least 6 months in the last two years Knowledge of FAA regulations Computer applications experience Ability to lead and motivate teams and individuals. Ability to work under pressure and to meet demanding deadlines. Strong interpersonal and leadership skills Good communication skills Excellent organizational skills Ability to work under pressure and demanding deadlines. Fluent in English and Spanish (both written and spoken) This job description reflects management's assignment of essential functions; it does not exclude or restrict the tasks that may be reasonably assigned.

The Quality Technician will assist in the execution and documentation of quality control activities, focusing on inspection processes, document review, and support for manufacturing area(s). Responsibilities: Review production documentation per batches. Assist in the revision of incoming inspection documentation. Perform quality checks on assembly and inspection lines using established techniques. Document inspection results and escalate non-conformances. Maintain compliance with internal procedures and regulatory requirements. Apply regulatory compliance and quality practices in a regulated manufacturing work environment. Other assigned duties, as assigned. Qualifications: Bachelor´s degree in Science, Administration, Engineering, or related field. Minimum of 3 years of experience in quality assurance for manufacturing industries. Familiarity with validation documentation and inspection protocols. Detail-oriented with strong documentation and communication skills. Bilingual (English/Spanish) preferred. Work Methodology: 100% On-site and Full-time project 13 months (1st Contract) Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need). Professional services contract

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: 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 litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Qualifications: Bachelor's degree in Science or Engineering 8+ years of related experience Previous experience on Quality Systems & CAPA, Change Control and Validations Knowledgeable on Medical Device Regulatory Requirements Previous experience with Quality & Regulatory Audit activities Shift: 1st 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.

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: With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Responsibilities: Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Assist with generation of process validation protocols and reports. Assist with the execution of the process validation. Support collection and analysis of process validation data. May participate in regulatory inspections Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Assist manufacturing change owner on CCRB packages impacting the process. Participate on the assessment or implementation of special projects or initiatives. Shift: Administrative Location: Juncos, PR Education: Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate's degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience. Academic background in Engineering disciplines, particularly Life Sciences, Engineering, Biotechnology, Chemistry, or a related technical discipline Preferred Qualifications: Engineering Experience in Manufacturing Operations - Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar). Technical Knowledge - Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis). Problem-Solving Skills - Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization. Cross-Functional Collaboration - Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment. Regulatory / GMP Knowledge - Understanding of cGMP, compliance, and documentation practices for regulated industries. Additional Strengths - Strong communication, adaptability to change Skills: Detailed technical understanding of bioprocessing unit operations. Skilled in performance of GMP production operations. Regulatory knowledge and interactions. Participate and help lead cross-functional teams. Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality. Organizational, technical writing and presentation skills. Basic project management skills. Basic knowledge of control charting. 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

Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Requirements: Experience writing SOP Experience in equipment / process Create new SOP's provide training to manufacturing personnel. Responsibilities: Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. Provide troubleshooting support. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Assist with generation of process validation protocols and reports. Assist with the execution of the process validation. Support collection and analysis of process validation data. May participate in regulatory inspections. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Assist manufacturing change owner on CCRB packages impacting the process Participate on the assessment or implementation of special projects or initiatives. Education: Doctorate degree or master's degree and 3 years of Manufacturing Operations experience or bachelor's degree and 5 years of Manufacturing Operations experience.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for, products or materials that do not meet required standards and specifications. • Reviews and analyzes quality trends with the manufacturing team. • Considering the quality trends provides directions in terms of setting work priorities for process enhancement. • Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented. • Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it. • Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process. • Analyzes data based on trends, recommends actions for process, equipment and system improvement. • Writes procedures, protocols and any other documentation needed for the enhancement of systems. • Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools. • Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions. • Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability. • Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring. • Drives SPC or preventive action methods. • Reviews and approves qualification / validation reports, ECO's/CA's, process changes, quality records or manufacturing documentation. • Implements quality system improvements. • Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits. • Integrates Quality Systems Regulations into New Product & Technology Development.  Performs other position duties as assigned.

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?

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"}

The Manufacturing Excellence (ManEx) Specialist at Bacardi is a key driver of operational excellence, responsible for analyzing, optimizing, and sustaining manufacturing processes to deliver improvements in quality, service, productivity, and efficiency. This role supports the implementation of the Bacardi Operating System (BOS), Lean Manufacturing, and Kaizen methodologies, collaborating across all levels and departments to foster a culture of continuous improvement. RESPONSIBILITIES - WITH OUR CONSUMER AT THE HEART YOUR KEY FOCUS WILL BE * Process Optimization: Analyze workflows, identify inefficiencies, and implement solutions to reduce waste, improve throughput, and lower costs using data-driven approaches and Lean Six Sigma tools. * Project Leadership: Lead cross-functional CI projects in partnership with Operations, Quality, Supply Chain, Maintenance, and Engineering. * Bacardi Operating System (BOS) Implementation: Own BOS pillars for the site, ensuring effective deployment and adherence over time through initiatives such as OGSM, DDS, Kaizen events, Gemba walks, 5S, etc. * Participates and owns metrics at the corresponding tier level such as Improvement Ideas, Center Lines, Change Overs, Kaizens, etc. * Training & Coaching: Facilitate Kaizen events, workshops, and training sessions to educate and mentor staff and primos in Lean, Six Sigma, and BOS principles. * Problem Solving and Root Cause Analysis: Facilitate problem-solving activities for process issues and use structured methods (e.g., 5 Whys, fishbone diagrams) to identify root causes of defects or inefficiencies. * Performance Monitoring: Establish and track KPIs, analyze data to measure impact, and adjust strategies as needed. * Documentation & Reporting: Maintain updated applicable SOPs, process maps, and improvement records. Prepare and present progress reports to management and stakeholders. * System Establishment & Performance Assurance: Develop and implement robust systems and standardized processes to support continuous improvement initiatives across the site. Conduct regular audits and assessments to verify that systems are operating effectively and consistently meet established standards. Utilize feedback loops and performance data to drive ongoing refinement, ensuring sustained compliance and optimal results. * Quality & Safety Compliance: Ensure all improvements align with Bacardi's safety standards and quality regulations. * Strategic Alignment: Work with managers and leadership to align CI initiatives with Bacardi's strategic goals. * SME on efficiency and productivity Computer Monitoring Systems. SKILLS - THE SKILLS AND EXPERIENCE NEEDED TO CREATE YOUR LEGACY * Education: Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Operations Management, or related field. Advanced degrees preferred. * English Level: Intermediate (B1-B2) required; higher proficiency is strongly preferred, especially for presentations and cross-functional communication. * Microsoft Office Skills: Advanced Excel and PowerPoint are mandatory (data analysis, KPIs, process reporting, effective presentations). Strong proficiency in Outlook and Microsoft Teams is also required. * Certifications: Lean Six Sigma (Yellow/Green) or equivalent. Familiarity with Kaizen, and BOS methodologies. * Experience: +5 years in manufacturing operations, with hands-on experience in process improvement, Lean manufacturing, and project management. * Technical Skills: Proficiency in data analysis, process mapping, and project management. Knowledge of ERP/MES systems is a plus. * Leadership & Communication: Strong ability to lead teams, influence without authority, and communicate effectively across all organizational levels. * Analytical & Problem-Solving: Expertise in root cause analysis, statistical process control, and structured problem-solving frameworks. * Attention to Detail: Detail-oriented with disciplined process documentation and follow-through. * Data Driven: Decision making and process improvement driven by performance data. * Demonstrate a positive attitude, strong work ethic and attention to detail, without close supervision. * Follow all policies/procedures, risk management, safety precautions, rules, regulations, and emergency procedures established at the facility. * Organize and prioritize work to meet deadlines. * Work effectively under pressure. * Work independently, exercising judgment and initiative. * Must be honest, trustworthy, reliable, dependable and strive to do the best job possible under all circumstances. * Remain flexible and adjust to situations as they occur. * Understand and behave in alignment with the Bacardi pillars of Fearless, Founder and Family LEADERSHIP AGILITY At Bacardi we care deeply about finding brilliant talent who can bring the following personal attributes to help elevate our 3Fs: Fearless, Family, Founder culture to the next level. * Belonging: You have a strong capacity to create a culture of 'Belonging', where people feel appreciated for who they are, what they do, and who they can become * Self-Awareness: You have high levels of self-awareness, are reflective and know yourself well, understanding both your own strengths and weaknesses and your impact on others * People Agility: You bring a deep ability to understand and relate to people and navigate through tough situations to harness and multiply collective performance * Results Agility: You demonstrate consistent delivery of results in first-time situations by inspiring teams, exhibiting a presence that builds confidence in yourself and others. * Mental Agility: You can think critically to penetrate complex problems and expand the possibilities by making fresh connections. You think strategically whilst being execution focused and bring creativity to the challenges you're presented with * Change Agility: You have a deep natural curiosity, desire to experiment and ability to effectively deal with the heat of change. You have a growth and learning mindset: ready to test, stumble, learn and apply from experience Disclaimer: Bacardi seeks talent from all backgrounds to bring diversity of thought, agility and capability to our organization across the globe. We promote a working environment where all employees are treated and rewarded fairly. We do not tolerate any form of discrimination that adversely affects individuals or groups on the basis of national origin, race, color, religion, sex, gender, sexual orientation, marital status, disability, age, and any other legally protected aspect of a person's identity. U.S. applicants have rights under Federal Employment Laws. Perks of Working for us At Bacardi, we are committed to providing our Primos (employees) with a comprehensive Total Rewards package of compensation, benefits, incentives, allowances, well-being, and much more to meet the needs of themselves and their families. It goes beyond just Cash! The total rewards program is based on pay for performance, whereby the incentive programs are linked to company and individual performance. Compensation, Paid Time Off & Retirement: * Competitive Pay Package * Competitive Holiday/Paid Time Off, plus additional days offered ( i.e., volunteer day, allowing you to give back to the community) * Retirement/Pension Plan Health & Wellbeing * Medical, Critical Illness, and Life Insurance * Calm Meditation App subscription (free) * Employee Assistance Programs * Best-in-class, family-friendly, and inclusive leave policies Additional Benefits The benefits /perks may vary depending on the nature of your employment with Bacardi, your work location, and are subject to change. Some benefits may be subject to an employee contribution. Some benefits may be fully or partially subsidized. Incentive plans are linked to the nature of your employment and can vary based on region, market, function or brand.

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

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, manufacturing operations among other services. Job Description Development and execution of Laboratory Equipment Validation. Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of related validation protocols. Development of documentation packages for all activities, including: Original format documents, approved document and applicable drawings. Qualifications Bachelor Degree in Chemistry or related discipline Experience developing Validation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Validation Experience in Computer Systems 21 CFR Part 11 practical knowledge Strong knowledge in GMPs regulations Technical Writing Experience Validation expertise in: Sterilization Kaye Validator & Data loggers Process Validation Equipment Qualification Re-qualification Computer System Validation Additional Information Positions available for Puerto Rico. Only candidates that meet the minimum requirements will be considered. Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

Job Description TITLE: Service & Quality Coordinator REPORTS TO: Unit Director STATUS: o Full time - Hourly ü Full time - Salary o Part Time - Hourly CLASIFICATION (FLSA): üExempt o Non-Exempt GENERAL DESCRIPTION: Responsible for registering the attendance of the participants daily, keeping the data updated in the system, and monitoring compliance with the proposals that subsidize the operations. It establishes strategies to guarantee the retention of the participants and offers suggestions to the leaders of Health and Life Skills, education, Recreation and Sports, Youth Development, Career Development, and Employability among others on the effectiveness, quality, and efficiency of the programs. TASKS AND DETAILED WORK ACTIVITIES: Keeps the membership system up to date with the correct and updated data. Enroll all participants and maintain a record of all required documents. Guides all participants on the important aspects and benefits of the club and guarantees that they use the membership card. Evaluate the frequency of the participants' attendance, identify trends and analyze the results to ensure that the Unit is meeting the requirements of the proposals. Make the required reports on time and with accurate information. In addition, it offers suggestions and proposes strategies to support the programs. Ensures security, promotes a risk-free environment, and maintains the proper appearance of the reception area. Supports the Unit Director Leader in analyzing the effectiveness of the club and the operation in general. Coordinate activities in the community to market the club and in turn meet the required attendance of participants, as well as retention and impact on other youth. Communicate and distribute information about upcoming events and activities. Develops solidarity with other Clubs and other non-profit organizations to establish links with professionals in the community; visits program participants' schools at least once per semester. In addition, it will establish and promote alliances with the schools of the participants. Promote customer service in your area and throughout the Club and is a positive example inside and outside it. Identify and manage possible risk situations for the Unit's operations. Know and serve the clientele of donors, participants, families, and communities. Oversees and evaluates the performance of the Maintenance Leaders and Safety Leaders to ensure compliance with action and work plans. Perform any other task requested by the supervisor. SUPERVISORY RESPONSIBILITIES: Determine schedules, sequences, and assignments for work activities, based on work priority and skill of personnel. Provide guidance and direction to subordinates, including setting performance standards and monitoring performance. Encouraging and building mutual trust, respect, and cooperation among team members. Identify the developmental needs of others, developing formal educational or training initiatives, such as, coaching, mentoring, or otherwise helping others to improve their knowledge or skills. Confer with personnel, to coordinate work activities, resolve employee grievances, or identify and review resources needed. Inspect and monitor work areas, examine tools and equipment, and provide employee safety training to prevent, detect, and correct unsafe conditions or violations of procedures and safety rules Recommend or initiate personnel actions, such as hires, promotions, transfers, discharges, or disciplinary measures. EXPERIENCE, EDUCATION, SKILLS & KNOWLEDGE REQUIRED: Bachelor of Business Administration from an accredited university and one (1) year of related experience. Grade Associate of Business Administration, Computer Information System or Office System from an accredited university and one (1) year of related experience. Administrative - Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology. English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. Personnel and Human Resources - Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems. Communicating with Supervisors, Peers, or Subordinates - providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. Coordinating the Work and Activities of Others - getting members of a group to work together to accomplish tasks. Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems Making Decisions and Solving Problems - analyzing information and evaluating results to choose the best solution and solve problems. Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards. Data or Information Analysis - Identifying the underlying principles, reasons, or facts of information by breaking down the information or data into separate parts. Monitor Processes, Materials, or Surroundings - monitoring and reviewing information from materials, events, or the environment, to detect or assess problems. Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making. PHYSICAL REQUIREMENTS & WORK ENVIRONMENT: Individuals may need to sit or stand as needed. The position may require walking primarily on a level surface for periodic periods throughout the day. May reach above shoulder height or below the waist and lift as required to file documents or store materials throughout the workday must be able to lift 15 pounds and use proper lifting techniques. Works in a dynamic environment with children and young people, which can vary as necessary. It is continually transported from one place to another. Standing or sitting and speaking or listening are regularly required. Ability to use common office equipment such as computers, facsimiles, printers, calculators, etc. You are frequently required to drive motor vehicles. DISCLAIMER: The information presented indicates the general nature and level of work expected of employees in this classification. It is not designed to contain, nor to be interpreted as, a comprehensive inventory of all duties, responsibilities, qualifications, and objectives required of employees assigned to this job. An Equal Employment Opportunity Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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: With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Responsibilities: Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Assist with generation of process validation protocols and reports. Assist with the execution of the process validation. Support collection and analysis of process validation data. May participate in regulatory inspections Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Assist manufacturing change owner on CCRB packages impacting the process. Participate on the assessment or implementation of special projects or initiatives. Shift: Non-Standard Shift / 8hrs shift Location: Juncos, PR Education: Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate's degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience. Preferred Qualifications: Experience writing SOP, experience in equipment / process, create new SOP' and provide training to manufacturing personnel. Skills: Detailed technical understanding of bioprocessing unit operations. Skilled in performance of GMP production operations. Regulatory knowledge and interactions. Participate and help lead cross-functional teams. Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality. Organizational, technical writing and presentation skills. Basic project management skills. Basic knowledge of control charting. 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

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. FUNCTIONS: 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. REQUIREMENTS: EDUCATION High school/GED + 10 years of directly related experience. Associates + 8 years of directly related experience Bachelors + 4 years of directly related experience Masters + 2 years of directly related experience Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes. Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering 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 COMPETENCIES/ SKILLS: Understand, support and demonstrate the AMGEN 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. WORK METHODOLOGY: Full on site job in Juncos, PR Full time job Expected project duration: 7 months for the first contract Administrative shift from Monday to Friday Professional services contract with potential extension based on performance and budget Expected hiring date: January 2026

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: 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 litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Coaches and reviews the work of lower level specialists Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Qualifications: Bachelor's degree in related area 4 years of relevant experience with Quality systems Investigation and root cause analysis skills Technical writing knowledge. Organization and Communication skills Process Validation and Computer software validation knowledge Availability for 1st 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.

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: 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 (typically University). DIFFERENTIATING FACTORS AUTONOMY: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience. Must have: • Performed and/or reviewed process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory) • Knowledge in Med Devices regulations • Experience working and executing Design transfer activities • Experience with implementation of new products: design requirements validation, manufacturing controls • Experience with Risk management documentation: pFMEAs • Basic knowledge in statistics • Basic knowledge in designing validation strategies

Performs complex tests and analyses to assure that products comply with established specifications. Carries out difficult calculations and prepares documentation that shows the results of tests performed. Completes record of inspection results, acceptance, rejection and disposition. Enters data into log books or computer databases. Compiles data and prepares reports on findings. Conducts scheduled calibration and maintenance on test equipment. Establishes maintenance and calibration schedule for test equipment based on manufacturers' recommendations and maintains equipment records. Coordinates specialized product\/customer quality testing. Prepares custom reports on results. Recommends and implements revisions, corrections and changes to test equipment, procedures and methods. Troubleshoots defective products returned by customers to determine root causes of failure. Compiles data to identify trends and proposes corrective action. Initiates and coordinates discussions with quality, engineering and other relevant departments to develop corrective actions for reoccurring problems. Requirements Minimum 4 to 6 years of relevant experience in the regulated industry. Bilingual. High school, technical or associate degree completed. "}}],"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":"Anasco"},{"field Label":"State\/Province","uitype":1,"value":"Anasco"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"00610"}],"header Name":"QC\/QA Technician","widget Id":"118922000006310086","is JobBoard":"false","user Id":"118922000000026001","attach Arr":[],"custom Template":"1","is CandidateLoginEnabled":true,"job Id":"118922000017022001","FontSize":"15","location":"Anasco","embedsource":"CareerSite","indeed CallBackUrl":"https:\/\/recruit.zoho.com\/recruit\/JBApplyAuth.do","logo Id":"nrt0md43109f3de4c490e9975771d2b120574"}