Specialist Quality Assurance
Guarda esta oferta y sigue tu búsqueda
Crea una cuenta gratis para guardar empleos, crear alertas y volver a esta oferta desde tu panel.
Al continuar, aceptas nuestros Términos & Política de Privacidad.
We are seeking a Specialist Quality Assurance to provide on-the-floor Plant Quality Assurance (PQA) support for Drug Substance operations at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role ensures that manufacturing processes, records and changes meet cGMP requirements and site procedures, and partners closely with Manufacturing, Process Development, Validation, Quality Control and Engineering.
Key Responsibilities
Perform on-the-floor PQA review, approval and tracking of cGMP processes, procedures, documents and records, including batch record review in MES/EBR, SAP and electronic quality systems.
Ensure on-the-floor triage of deviations is completed and documented, and that deviations are investigated per procedure.
Ensure changes potentially impacting product quality are assessed according to procedures.
Ensure production records and testing results are complete, accurate and documented per cGMP requirements.
Support internal and external audits and inspections, acting as Quality unit representative as needed.
Provide Quality support and oversight for New Product Introduction (NPI) and serve as Quality contact for complex projects.
Review and approve validation deliverables for GxP applications and equipment (VMP, IQ/OQ/PQ, risk assessments, test scripts and summary reports).
Champion continuous improvement initiatives and projects.
Requirements
Education
Bachelor's degree in Science or Engineering + 4 years of directly related experience
Preferred Qualifications
Demonstrated expertise in Quality Systems such as deviations, CAPA and change control
Experience in computer systems validation or computer systems quality assurance
Experience in commissioning and qualification and validation of GxP applications
Strong knowledge of manufacturing, distribution, QA and Process Development processes
Experience with MES, EBR, SAP and Trackwise or similar systems
Key Skills
Strong communication skills in English and Spanish (written and oral), facilitation and presentation skills
Strong organizational skills; enhanced leading, influencing and negotiating skills
Ability to interact effectively with regulatory agencies
Advanced data trending and evaluation; ability to evaluate compliance issues
Able to work independently and interact effectively at all levels of the organization
Benefits
Contract position: approximately 6.5 months (October ** – April **), with possible extension
Shift: Non-standard shift
Schedule: 12-hour shifts (approximately 48 hours/week)
On-site in Juncos, Puerto Rico
-
Specialist Quality Assurance
Hace 6 días
Juncos, Juncos, Puerto Rico Amgen Jornada completaUS - Puerto Rico - JuncosJOB ID: R-****** LOCATION: US - Puerto Rico - Juncos WORK LOCATION TYPE: On Site DATE POSTED: Oct. 15, **** CATEGORY: QualityJoin Amgen's Mission of Serving PatientsAt 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...
-
Specialist Quality Assurance
Hace 2 semanas
Juncos, Juncos, Puerto Rico Innovaworkforce Inc. Jornada completa*SUMMARY*Perform one or more of the following duties and responsibilities in support of Company's Quality Assurance program under minimal supervision.*PREFERRED QUALIFICATIONS** Preferred Educational background in Life Sciences and/or Engineering.* Expertise in Quality Systems, including Deviations (Non conformities), CAPA, and Change Control.* Experience...
-
Analyst 2 - Quality Assurance
Hace 1 semana
Juncos, Juncos, Puerto Rico Prpdg Jornada completaQuality Assurance to support quality assurance programs, procedures, and controls while driving continuous improvement and ensuring compliance with applicable quality standards and GMP requirements.ResponsibilitiesMonitor and track quality detractors through service and complaint databases.Ensure compliance with company policies, procedures, quality...
-
Quality Engineer Ii
Hace 6 días
Juncos, Juncos, Puerto Rico Minimed Jornada completaAt MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.About the RoleEvery product we deliver carries a patient's trust. As a Quality...
-
Quality Engineer Ii
Hace 7 días
Juncos, Juncos, Puerto Rico Medtronic Jornada completaCareers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique...
-
Specialist Qa
Hace 1 semana
Juncos, Juncos, Puerto Rico Qrc Group Llc Jornada completaWe are seeking a Specialist QA with experience in regulated industries: Responsibilities: Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations,...
-
Specialist Qa
Hace 1 semana
Juncos, Juncos, Puerto Rico Amgen Jornada completaUS - Puerto Rico - JuncosJOB ID: R-****** LOCATION: US - Puerto Rico - Juncos WORK LOCATION TYPE: On Site DATE POSTED: Oct. 12, **** CATEGORY: QualityJoin Amgen's Mission of Serving PatientsAt 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...
-
Specialist Quality Assurance
Hace 2 semanas
Juncos, Juncos, Puerto Rico Biopharma Consulting Jad Group Jornada completaWe are seeking a Specialist Quality Assurance to support the Drug Product Quality Assurance technical team at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. Working under minimal supervision, this role provides Quality oversight of manufacturing, packaging and inspection operations, ensuring compliance with cGMP and site quality...
-
Inspector I
Hace 5 días
Juncos, Juncos, Puerto Rico Medtronic Jornada completaCareers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique...
-
Quality Assurance Specialist
Hace 2 semanas
Juncos, Juncos, Puerto Rico Fits, Llc Jornada completa*WHAT MAKES YOU A FIT: **The Technical Part:** Bachelor's Degree with four (4) years of experience within the pharmaceutical or regulated industry.* Bilingual (English & Spanish).* Project Management skills.* Shift: Administrative and according to business needs.* Experience in:* Quality Assurance, including review and approval of change controls,...