Regulated Industry Expert

hace 2 semanas


Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

Job Summary:
Flexible & Integrated Technical Services, LLC is seeking a highly skilled Regulated Industry Expert to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and validating manufacturing processes.

Responsibilities:

  1. Review and validate product MPRs
  2. Develop and implement process validation protocols
  3. Participate in incident triage teams and lead investigations
  4. Develop and maintain environmental characterization reports
  5. Ensure compliance with regulatory requirements
  6. Validate manufacturing processes
  7. Represent QA on NPI teams
  8. Own site quality program procedures
  9. Develop and implement CAPA records and NC investigations
  10. Provide lot disposition and authorize lots for shipment

About Our Company:

We are a Service Provider company that values our employees and provides them with opportunities for growth and development. We offer a flexible and family-oriented work environment while delivering high-quality services to our clients.



  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    About the Role">The validation engineer will be responsible for developing and implementing validation strategies for laboratory instruments and equipment. This includes designing and executing qualification protocols, assessing data integrity, and ensuring compliance with regulatory requirements.">Key Responsibilities">">Design and execute qualification...


  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Job Description:This is an exciting opportunity for a seasoned Quality Professional to join our team as a Technical Quality Assurance Specialist. The successful candidate will have a strong background in quality assurance, excellent communication skills, and a commitment to serving customers with high-quality research and products.Key Responsibilities:Lead...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    GMP Manufacturing ExpertiseMentor Technical Group provides expert guidance and support to the life sciences industry, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. As a GMP Manufacturing Expert, you will play a critical role in helping our clients navigate the complex regulatory landscape and...


  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    We're looking for a skilled Regulatory Compliance Expert to lead our quality assurance efforts in the Inspection area. As a member of our team, you will play a key role in ensuring regulatory compliance and maintaining the highest quality standards.About This RoleThis position requires a strong background in regulatory compliance and quality assurance. The...


  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Job DescriptionWe are seeking a skilled Manufacturing Operations Specialist to join our team. In this role, you will be responsible for initiating, revising and approving manufacturing procedures, ensuring all procedures reflect current operations, serving as a document owner, assessing process performance by observation of floor operations and review of...


  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Job Summary:The Technical Quality Assurance Specialist will play a critical role in ensuring that our quality standards are met and exceeded in the pharmaceutical industry. This position requires a highly motivated and experienced quality professional who can lead investigations, represent QA on the NPI team, and own site quality program...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Overview">Mentor Technical Group, a world leader in life science engineering and technical solutions, offers a comprehensive portfolio of support and services for the FDA-regulated industry. We have offices in Caguas, Puerto Rico, and Boston, serving clients in six global markets.">About the Role">We are seeking an experienced Technical Solutions Expert to...


  • Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

    **About Us**Biopharma Consulting Jad Group is a leading consulting firm specializing in biopharmaceutical development and manufacturing. We offer expert services in validation and compliance management, helping our clients navigate the complexities of regulatory requirements and industry standards.We are committed to delivering high-quality services that...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    About Mentor Technical GroupMentor Technical Group is a world leader in life science engineering and technical solutions, providing comprehensive support and services to the FDA-regulated industry.

  • Asset Management Expert

    hace 1 semana


    Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Our Company CultureWe are a family-oriented company that values its resources and clients. We are flexible and focused on our resources' well-being while providing top-notch quality talent to our clients.Job DescriptionWe are seeking an experienced Maximo Specialist to join our team. As a Maximo Specialist, you will be responsible for managing and creating...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Mentor Technical Group provides comprehensive technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering, we have the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.Responsibilities: Collaborate with engineers to develop...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Mentor Technical Group offers a unique opportunity for experienced professionals to join our team as Sr. Data Scientist. With a strong focus on life science engineering and technical solutions, we deliver cutting-edge services that meet the needs of the FDA-regulated industry. Our team consists of experts who collaborate closely with clients across various...


  • Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    Job OverviewWe are seeking a highly skilled Sr Validation Scientist to join our team at Qrc Group Llc. This role requires expertise in validation processes, particularly in regulated environments such as Biotechnology, Pharmaceutical, and Medical Devices.The ideal candidate will have experience in independently providing technical validation engineering...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Key ResponsibilitiesThe successful candidate will be responsible for:">Providing troubleshooting support as required by operations/engineeringAnalyzing downtime incidents and preparing recommendationsCreating action plans to eliminate recurrenceParticipating actively in the support of High Skills equipment breakdownsPerforming or reviewing equipment/system...

  • Validation Expert

    hace 1 semana


    Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Mentor Technical Group provides technical support and solutions for the FDA-regulated industry. Our team has extensive knowledge and experience in ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.Our MissionWe strive to deliver high-quality services that meet the needs of our clients. Our focus areas...


  • Juncos, Puerto Rico Eqval A tiempo completo

    Company OverviewEQVAL Group, Inc. provides expert services to the manufacturing industry, serving clients in Medical Devices, Pharmaceuticals, and Biotechnologies.Job DescriptionWe are seeking a skilled Manufacturing Engineer to join our team. The ideal candidate will have experience in Medical Device or Pharmaceutical industries and will be responsible for...


  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    Job Summary:We are seeking a Production Optimization Expert to join our team. The ideal candidate will have a strong background in manufacturing engineering and experience in designing and developing efficient manufacturing processes.About the Role:The successful candidate will be responsible for designing and developing manufacturing processes, procedures,...


  • Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Requirements and QualificationsTo be considered for this position, applicants must possess a Doctorate degree or Master's degree with 3 years of experience in manufacturing operations, or Bachelor's degree with 5 years of experience, or Associate's degree with 10 years of experience, or High school diploma/GED with 12 years of experience.


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Job SummaryMentor Technical Group, a leading provider of technical support and solutions for the FDA-regulated industry, is seeking an experienced Document Control Specialist to join our team. In this role, you will be responsible for ensuring the accuracy and completeness of technical and operational translated documentation.The successful candidate will...


  • Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Overview of Mentor Technical GroupWe are a global provider of life science engineering and technical solutions. Our comprehensive portfolio includes technical support and solutions for the FDA-regulated industry.We have a strong presence in various markets, including the United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South...