Se Busca: Quality Consulting Group, Inc. Regulatory Affairs Manager

title
Quality Consulting Group, Inc. Regulatory Affairs Manager
DESCRIPCION
The Regulatory Affairs Manager will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. Primary responsibilities include develop regulatory strategies for reporting post approval changes, preparation of critical CMC submission documentation, assessment of change control, non-conformances and other quality related documents, and the preparation of the annual report of minor changes. Participate in general regulatory affairs and regulatory compliance functions of the company.
REQUISITOS
BS degree in Science (e.g. Biology, Chemistry, Biochemistry) and 5 years of experience in Quality area. Managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources. Experience with biotechnology products, regulated industry, science or GMP practice experience. *** Strong oral and written communications in Spanish and English. ******STRONG COMMUNICATION SKILLS**** ORAL AND WRITTEN (ENGLISH AND SPANISH) *** Please send qualified resume in English to: careers@qualityconsultinggrouppr.com ****
contact
Contacto – Contactrn Quality Consulting Group, Inc.rn Quality Consulting Group, Inc. 787-418-0240

Se Busca: Quality Consulting Group, Inc. Senior Validation Engineer

title
Quality Consulting Group, Inc. Senior Validation Engineer
DESCRIPCION
REQUISITOS
*Education: B.S./B.A in Engineering or Science or related field or 4 years of relevant work experience in lieu of education requirement. ******MUST BE FULLY BILINGUAL… English/Spanish… SPEAKING, WRITTEN AND READING **** *** Please send qualified resume in English to: careers@qualityconsultinggrouppr.com ****
contact
Contacto – Contactrn Quality Consulting Group, Inc. 787-418-0240

Se Busca: Quality Consulting Group, Inc. SCIENTIST MEDICAL DEVICE/PHARMACEUTICAL

title
Quality Consulting Group, Inc. SCIENTIST MEDICAL DEVICE/PHARMACEUTICAL
DESCRIPCION
Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
REQUISITOS
Doctorate or Master’s degree and 3 years of directly related or Bachelor’s Degree in Science (Engineering, Physics, Chemistry, Biology) 5+ years of experience in manufacturing processes, preferably on filling process of biotechnology derived products, on including but not limited to the following roles or positions: Process Development Scientist Process Development Engineer Manufacturing Engineer Manufacturing Specialist Process Owner System Owner / Process Scientist Process Engineer Experience in design of experiments and sampling plan development Experience in leading a development or validation activity execution Experience in Standard Deviation, Process Capability. Experience writing protocols, reports, assessments **MUST BE FULLY BILINGUAL… English/Spanish… SPEAKING/WRITTEN *** Please send qualified resume in English to: careers@qualityconsultinggrouppr.co
contact
Contacto – Contactrn Quality Consulting Group, Inc.rn Quality Consulting Group, Inc. 787-418-0240

Se Busca: Quality Consulting Group, Inc. Senior Electrical Technician

title
Quality Consulting Group, Inc. Senior Electrical Technician
DESCRIPCION
REQUISITOS
Associate’s degree in Instrument Tech & 4 years of directly related experience or High school diploma / GED & 6 years of directly related experience. Available to work 2nd shift. A highly skilled craftsperson knowledgeable in installation, maintenance, and design of electrical equipment. Advanced knowledge of Power Distribution Systems, UPS Systems, Variable Speed Drives, Emergency Generators, Motors, Breakers and Motor Control Centers.
contact
Contacto – Contactrn Quality Consulting Group, Inc.rn Quality Consulting Group, Inc. 787-418-0240

Se Busca: Quality Consulting Group, LLC CAPA EXPERT (NCR)

title
Quality Consulting Group, LLC CAPA EXPERT (NCR)
DESCRIPCION
Experience and strong knowledge of GMP, FDA regulation, etc. Previous experience on Medical Devices and/or Pharmaceutical Industry. Experience doing NCR (non conformance reports) / QIR (Quality Investigation Reports) / CAPAS(manufacturing and packaging). Experience on corrective and preventive action system (CAPA). Proven experience doing statistical analysis. Knowledge and hands-on experience working with Risk Management and Change Control Systems.
REQUISITOS
Bachelor’s degree in Engineering and 5 years of directly related experience. Minimum 5 years in FDA Regulated Industry. COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral). ******Strong communications skills… English and Spanish **** *** Please send qualified resume in English to: careers@qualityconsultinggrouppr.com ****
contact
Contacto – Contactrn Quality Consulting Group, LLCrn Quality Consulting Group, LLC 787-418-0240

Se Busca: Quality Consulting Group, Inc. COORDINADOR (A) DE TRAFICO / LOGISTICA

title
Quality Consulting Group, Inc. COORDINADOR (A) DE TRAFICO / LOGISTICA
DESCRIPCION
Experiencia en Transportacion, Leyes de Transportacion, Documentacion. Experiencia en coordinacion de Trafico local, Trafico Aereo, Trafico Maritimo.
REQUISITOS
BA completado en area relacionada. Certificacion del DOT, y 49 CFR. ****DISPONIBILIDAD INMEDIATA***** *** Buena comunicacion escrita y verbal (Ingles y Espanol)…. *** Si cumple con TODOS los requisitos favor de enviar resume a: careers@qualityconcultinggrouppr.com inmediatamente.*****
contact
Contacto – Contactrn Quality Consulting Group, Inc. 787-418-0240

Se Busca: Quality Consulting Group, Inc. SR ENGINEER *** MEDICAL DEVICE/PHARMACEUTICAL

title
Quality Consulting Group, Inc. SR ENGINEER *** MEDICAL DEVICE/PHARMACEUTICAL
DESCRIPCION
Ability and willingness to work any shift in support of operations that may include 24/7. Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Computer Based Training (CBT).
REQUISITOS
BS In Engineering is required… Experience in: Manufacturing Inspection processes, Performing evaluation results NC entries, Support Process Development Protocols Executions (Characterization protocols), Handling of Units for Process Development Evaluation, Machine Testing Certification and PQA delivery of the Inspection Challenge Units, Delivering evaluated confirmed units for further required evaluation. ALSO, Experience in Investigational Reports for Product Complaints and NCs, Prepare Experiments for Sample Evaluation, Technical Assessments for Investigations (NCs or Complaints), Data Verifications for investigations, DPPD (Drug Product Process Development) Sample Handling, Trainings …. ******STRONG COMMUNICATION SKILLS… English/Spanish… *** Please send qualified resume in English to: careers@qualityconsultinggrouppr.com ****
contact
Contacto – Contactrn Quality Consulting Group, Inc. 787-418-0240

Se Busca: Quality Consulting Group, Inc. Sr. Validation Scientist (Cleaning Validations)

title
Quality Consulting Group, Inc. Sr. Validation Scientist (Cleaning Validations)
DESCRIPCION
Experience with Software Validation Experience in equipment, cleaning and sterilization validation Cleaning Validation/ Equipment Validation/ Validation experience in aseptic process experience with parenterals
REQUISITOS
Doctorate degree in Sciences or Master’s degree in Sciences and 3 years of directly related experience or Bachelor’s degree in Sciences and 5 years of directly related experience. Experience in equipment, cleaning and sterilization validation. *** STRONG COMMUNICATION SKILLS (ENGLISH AND SPANISH)**** ** PLEASE SEND RESUME IN ENGLISH TO: careers@qualityconsultinggrouppr.com ****
contact
Contacto – Contactrn Quality Consulting Group, Inc. 787-418-0240