Jr Assoc, Quality Control

00739 Cayey, Puerto Rico West Pharmaceutical Services

Posted 5 days ago

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Jr Assoc, Quality Control
68795
Fecha:
17 ago. 2025
Ubicación:
Cidra, Puerto Rico, US
Departamento:
Quality
Descripción:
_En West, somos un equipo dedicado que está conectado por el propósito de mejorar las vidas de los pacientes que han estado en el centro de nuestra empresa durante más de un siglo._ _Nuestra historia comenzó cuando Herman O. West resolvió el problema del suministro de penicilina en cantidades masivas al Gobierno de EE. UU. durante la Segunda Guerra Mundial. Gracias a nuestro trabajo para suministrar miles de medicamentos inyectables que salvan y mejoran vidas a millones de pacientes cada día, la huella indeleble de West en la industria sanitaria acaba de comenzar._ _Un nombre dio comienzo a nuestra historia. ¿Cómo nos ayudará el suyo a escribir nuestro futuro?_
_No hay mejor lugar para unirse a una comunidad inclusiva de profesionales con oportunidades de aprendizaje, crecimiento y desarrollo permanentes. Con el apoyo de programas de beneficios, fortalecemos la salud física, mental, emocional y financiera de los miembros de nuestro equipo y sus familias._
_Creemos en la retribución para ayudar a aquellos que lo necesitan en las comunidades donde vivimos y trabajamos. Y compartimos el compromiso con la creación de un planeta y un medioambiente más saludables a través de nuestros esfuerzos de sostenibilidad._
**Resumen del trabajo**
Responsable de asegurar la calidad del producto mediante una base de prevención basadas en iniciativas de calidad que incluyen: inspecciones de proceso de producto terminado, inspecciones de materia prima, participación activa en equipos de trabajo para identificar y corregir defectos. Asegura la consistencia en la ejecución de los procedimientos para lograr las metas del departamento, apoyo directo en validaciones de producto nuevo o mejoramiento a procesos de producto existente. Completa y mantienen la documentación necesaria para asegurar el cumplimiento con las especificaciones del producto y rastreabilidad de los registros de manufactura.
**Deberes y responsabilidades esenciales**
+ **Inspecciona los componentes del trabajo en proceso para asegurar la conformidad con las especificaciones del cliente, asegurar que solo material aprobado y certificado está listo para ser almacenado o utilizado en producción. Libera los componentes para ser utilizados en producción, audita las áreas de manufactura para asegurar el cumplimiento con los procedimientos.**
+ **Audita y aprueba los registros de manufactura y ejecuta la liberación del producto final.**
+ **Interpreta especificaciones y procedimientos, utiliza los equipos de prueba y medición según establecidos en el plan de Calidad, utiliza técnicas de control de calidad según requeridas.**
+ **Inspecciona y realiza pruebas a todo material que así lo requiera según el Procedimiento de Recibo de Materia Prima. Identifica, segrega y dispone de materia prima que este fuera de especificación. Si es requerido, brinda apoyo al departamento de Ingeniería en las actividades de validación, así como el uso correcto de equipos de medición y procesos. Participa en Equipos de transferencia de Moldes.**
+ **Ayuda en la implementación de adiestramientos al personal en todos los niveles para concientizar y asegurar el cumplimiento con el sistema de Calidad.**
+ **Participa en equipo con el área de producción para desarrollar planes de acción correctiva cuando sean necesarias. Junto con el supervisor de Calidad o Ingeniero de Calidad da apoyo técnico e identifica áreas de mejora continua para reducir producto no conforme.**
**Responsabilidades adicionales**
**Educación**
Destrezas Matemáticas: **Capaz de llevar a cabo procesos matemáticos de:**
+ **Suma, resta, multiplicación y divisi** **ón de números enteros, decimales y fracciones.**
+ **Calcular porcientos y "ratios".**
+ **Experiencia con equipo de medición tales como: "caliper", micrómetros, "pin guage", equipos de visión, balanzas de peso.**
+ **Destrezas básicas de herramientas de SPC.**
**Conocimientos,habilidades y habilidades preferidos**
+ Experiencia trabajando en industrias reguladas por el FDA.
__ _West acoge la diversidad y la igualdad de oportunidades. Fomentamos un entorno en el que todas las personas se sientan seguras, tratadas de manera justa, valoradas y respetadas. No discriminamos por motivos de raza, religión, color, origen nacional, género, sexo, identidad de género, orientación sexual, edad, estado civil, estado de veterano o estado de discapacidad u otras características aplicables que estén protegidas por la ley. Si la ley lo permite, una oportunidad de empleo en West Pharmaceutical Services, Inc., o cualquiera de sus empresas subsidiarias o afiliadas, está supeditada a la aprobación de controles de antecedentes o pruebas de detección de drogas posteriores a la oferta._
**Acerca de West**  
_El 2023 marca el hito de innovación de 100 años de West y el papel crítico que sigue desempeñando en la atención de la salud y la experiencia del paciente. Con un equipo de 10 000 miembros en 50 centros de todo el mundo, West suministra más de 47 000 millones de componentes y dispositivos cada año. Con sede en Exton, Pensilvania, West en su año fiscal de 2022 generó USD 2890 millones en ventas netas. West cotiza en la Bolsa de Nueva York (NYSE: WST) y está incluida en el índice Standard & Poor's 500. Para obtener más información, visite_ __ _ _._
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Sr. Associate Quality Control

00777 Juncos, Puerto Rico Kelly Services

Posted 9 days ago

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Job Description

**At Kelly** **®** **Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. How about this one?**
We're seeking a **Sr. Associate Quality Control** to work with one of out top biotechnology industry client at the East area of **PR.** With us, it's all about finding the job that's just right.
**Available to work an administrative shift.**
**Salary $30.00 p/h**
**Responsibilities:**
+ Perform routine laboratory procedures
+ May perform aseptic aliquot ting, sampling and analysis for compendia and non-compendia methods.
+ May perform non-routine lab procedures under close supervision.
+ Perform or review one or more of the following: sample testing,
+ Standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance.
+ Prepare complete, accurate, concise laboratory documentation.
+ Data entry, review, analysis and communication of results
**Requirements:**
+ Bachelor in Science and 6 months of experience in Quality Control
+ GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
+ Experience in development and validation testing of software used in a GMP environment.
+ Experience and knowledge in using electronic lab notebook systems.
+ Experience in testing or with processes involving analytical methods.
**What happens next**
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about, so let's get to work. Apply to be a Sr. Associate Quality Control today!
**Kelly PR Offers!**
+ Exposure to a variety of career opportunities as a result of our expansive network of client companies
+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career
+ Access to more than 3,000 online training courses through our Kelly Learning Center
+ Bi -weekly pay
+ Among other benefits!
** Apply Today! ( part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® ?
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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Senior Specialist Quality Control - Technical Resources

00777 Juncos, Puerto Rico Amgen

Posted 4 days ago

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Job Description

**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.
**Senior Specialist Quality Control - Technical Resources**
**What you will do**
Let's do this. Let's change the world! In this vital role you will be the technical specialist for Amgen Manufacturing Limited, QC Operations. **You will serve as a key technical leader supporting the Quality Control (QC) laboratories.** You will be responsible for addressing complex technical challenges with cross-functional, multi-site, and external impact. Collaborating across Quality Control, Quality Assurance, Manufacturing, Engineering, and Process Development, your work will be critical in ensuring the robustness and reliability of lab operations.
Specific responsibilities include but are not limited to:
+ **Technical Expertise & Troubleshooting -** Provide hands-on technical guidance and expert-level troubleshooting for analytical assays and laboratory equipment, ensuring high-quality and timely support across QC operations.
+ **Data & Reporting -** Conduct data analysis, generate technical reports, and maintain effective communication with cross-functional technical teams. Follow up on open items and drive issues to resolution.
+ **Compliance & Safety Leadership -** Ensure strict adherence to cGMP, GLP, and safety standards. Drive compliance through the development and implementation of procedures that enhance quality and safety across lab operations.
+ **Laboratory Optimization -** Lead initiatives to improve equipment reliability and maintenance using optimization techniques. Champion programs that elevate laboratory performance and minimize downtime.
+ **Controlled Documentation -** Create, revise, and audit complex controlled documents with potential multi-site impact. Ensure documentation aligns with regulatory and corporate requirements.
+ **Audit & Inspection Readiness -** Lead QC efforts during internal and external inspections. Serve as a key representative and subject matter expert (SME) for laboratory equipment and operations.
+ **Training & Capability Building -** Develop and deliver technical training programs for laboratory staff. Promote knowledge transfer and continuous improvement initiatives.
+ **Quality Systems Oversight -** Manage quality system records, lead laboratory investigations, and support continuous improvement of quality processes.
+ **Cross-functional Collaboration -** Represent QC Operations on cross-functional teams and global initiatives. Independently manage and drive multi-site action items to closure.
+ **Regulatory Engagement -** Support regulatory inspections and responses as an SME within area(s) of responsibility.
+ **Financial & Vendor Management -** Oversee operational financials, including procurement activities, contract execution, and purchase order management for laboratory services and equipment.
+ **Special Projects -** Lead or support strategic projects assigned by management to drive innovation and efficiency.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients! The Sr Specialist QC professional we seek is a collaborative individual contributor leader with these qualifications.
**Basic Qualifications:**
Doctorate degree and 2 years of quality control and/or laboratory experience
OR
Master's degree and 4 years of quality control and/or laboratory experience
OR
Bachelor's degree and 6 years of quality control and/or laboratory experience
Or
Associate's degree and 10 years of quality control and/or laboratory experience
Or
High School diploma / GED and 12 years of quality control and/or laboratory experience
**Beyond that, additional preferred qualifications are:**
+ Academic background in Life Sciences.
+ 10+ years of professional experience, including at least 4 years in cGMP-regulated environments within Quality Control, Laboratory Operations, Validation, or Quality Assurance.
+ Exceptional proficiency in analytical method qualification, validation, and transfer processes as well as their associated international guidance and regulatory requirements.
+ Strong technical background with laboratory equipment operation, troubleshooting, maintenance, and optimization in multiple analytical platforms (molecular biology, chemistry and/or microbiology).
+ Demonstrated experience managing quality systems, including Change Controls, CAPA, deviations, and investigations.
+ Proficient in cGMPs/GLPs, domestic and international regulatory standards, and experienced in regulatory inspection readiness and response.
+ Excellent technical writing, facilitation, and verbal communication skills in English; capable of authoring SOPs, protocols, and regulatory documentation clearly and effectively.
+ Skilled in data analysis, digital systems (LIMS, Empower), and Microsoft Office applications (Excel, Word, PowerPoint).
+ Proven ability to lead cross-functional teams and projects, with strong influencing, organizational, and project management capabilities, including budget oversight and capital project execution.
+ Strong commitment to EHS practices and promoting a culture of laboratory safety and compliance.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, life and 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
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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 all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
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.
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