Sr Associate Deviation Analyst
Flexible & Integrated Technical Services, LLC
For Deviation in the Quality Systems a rea.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree with two (2) years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative and according to business needs.
- Experience in:
- Deviation management within a GMP/GxP environment, ownership of major and minor deviations.
- Investigation lifecycle from initiation through closure.
- Computerized manufacturing systems, including platforms such as MES, Veeva, SAP, PCS, or PI Historian.
The Personality Part:
- Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Responsibility extends to multiple departments/functional areas.
- Demonstrates thorough knowledge of objectives and processes in multiple departments/functional areas supported.
- Promotes and develops communication between assigned business unit, technical staff, and vendors to integrate information systems.
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations.
- Conducts impact analysis of new products, systems, upgrades, and changes for multiple departments/functional areas.
- Evaluates systems and business processes for feasibility in multiple departments/functional areas. Able to recognize problems and communicate.
- Establishes and maintains positive business relationships with managers and staff in multiple departments/functional areas.
- Has a thorough understanding of the client?s business, their processes, and their priorities.
- Ensures system functionality and performance meet current and future business requirements. May apply principles, theories and concepts.
- Prepares complex documentation for assigned projects. (Refer to Project Deliverables, Appendix 1).
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in 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?
- For EHS services in the Occupational and Process Safety area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Environmental Health & Safety or related fields and an equivalent of two (2) years of experience in the regulated industry. Bilingual...SugeridoContratoTrabajar en la oficinaTurno de tardeTrabajo por turnos
- ...Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: Serve as the primary owner for deviations, ensuring proper documentation, investigation, and resolution in compliance with FDA and internal quality standards....Sugerido
- ...The candidate should bring strong experience in deviation management within a GMP/GxP environment, o wnership of major and minor deviations... ...’s degree and 2 years of directly related experience OR Associate ’s degree and 6 years of directly related experience OR...SugeridoContratoTrabajo por turnos
- ...and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. Employ advanced engineering techniques and/or...SugeridoContratoTrabajo por turnos
- ...and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. Employ advanced engineering techniques and/or...SugeridoContratoTrabajo por turnos
- ...regulatory fields. Log on now to our website qrcgroup.com / to learn more about our services and solutions! Job Description Sr Engineer with experience in Manufacturing Operations Hands-on experience in process engineering, man ufacturing support, or...Contrato
- ...policies and procedures that affect multiple organizational units. Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. Employ advanced engineering techniques and/or modifications...Tiempo completoTrabajo por turnos
- ...about our services and solutions! Job Description The Sr Data Scientist will lead projects and collaborate with business... ...analytics, engineering, computer science or related field experience or Associates + 8 years of data science, business, statistics, data mining,...Contrato
- ...assessments related to system qualification. • Evaluate and manage change controls impacting validated systems. • Assess impact of deviations and implement corrective and preventive actions (CAPA). 6. Cross-functional Coordination • Collaborate with Engineering,...ContratistaContrato
- ...regulatory fields. Log on now to our website qrcgroup.com / to learn more about our services and solutions! Job Description Associate Tech Engineering with experience with pneumatics, automatic control and vision inspection systems required. Responsibilities:...ContratoTrabajo por turnos
- ...responsibilities include but are not limited to: • Own change controls for manufacturin g process changes • Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive...Contrato
- ...Collaborates with Distribution in the selection of new Distributors and 3PLs. Define Receiving Inspection requirements as required and associated test method validation. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we...ContratoRemotoTrabajo por turnos
- ...policies and procedures that affect multiple organizational units. Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis. Employ advanced engineering techniques and/or modifications...Tiempo completoTrabajo por turnos
- ...For maintenance services in the manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: ~ Associate Degree with 5+ years of experience in industrial mechanics within the pharmaceutical or regulated industry. ~ Bilingual (English & Spanish). ~ Project...ContratoTrabajo por turnos
- ...mechanical and Troubleshooting services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: ~ Bachelor's Degree or Associate Degree with two (4) years of experience in the regulated industry. ~ Bilingual (English & Spanish). ~ Problem-solving and root...ContratoTrabajo por turnos
- ..., statistics, data mining, applied mathematics, business analytics, engineering, computer science or related field experience OR Associates + 8 years of data science, business, statistics, data mining, applied mathematics, business analytics, engineering, computer science...Tiempo completoTrabajar en la oficinaTrabajo por turnos
- ...regulatory fields. Log on now to our website qrcgroup.com / to learn more about our services and solutions! Job Description Sr Engineer with experience in biotechnology pharmaceutical process support, especially on Drug Substance processes, and GMP...Contrato
- ...Participate in receiving inspection programs to ensure supplier effectiveness. Define receiving inspection requirements and associated test method validations. Supplier Auditing & Performance Assessment Develop and execute supplier audit schedules. Conduct...Contrato
- ...ongoing support with detailed technical information and solving technical situations. Qualifications: ~ Bachelor's degree or Associate's degree in related area ~2 to 4 years of directly related experience ~ Experience with pneumatics, automatic control and...ContratoTrabajo por turnos
- For Quality services in the Manufacturing/Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Life Sciences and at least five (5) years of experience in Quality activities within the medical device industry. Bilingual...ContratoTrabajo por turnos
- ...for mechanical equipment. Support on-call response by maintaining a pager or cell phone while on-call. Qualifications: ~ Associate degree in Mechanical, Electrical, Industrial Maintenance, Mechatronics, or related technical field; or equivalent military/industry...TemporalTurno de tarde
- ...activities and coordinate with internal teams and external consultants to ensure timely delivery. Manage change controls and deviations related to plants and equipment. Support maintenance and calibration functions to improve compliance and quality. Provide expertise...Tiempo completoTrabajar en la oficina
- For Technical Services in the Scientist a rea. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with four (4) years of experience as a Scientist within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project Management...ContratoTrabajar en la oficinaTrabajo por turnos
- -Bachelor’s in engineering & over 4 years of Engineering experience -Mechanical, Electrical, or Industrial • Maintenance knowledge and experience with automated and manual inspection equipment operation. • Technical knowledge of inspection technologies for parenteral...Contrato
- Experience in C&Q process, Validation and Packaging. Requirements Doctorate OR Masters + 2 years of Engineering experience OR Bachelor’s in engineering + 4 years of Engineering experience. Preferred: Bachelor’s in engineering + 4 years of Engineering experience...
- • Familiar with distribution testing per ASTM D4169, International Organization for Standardization (ISO), Technical Association of the Pulp and Paper Industry (TAPPI), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP). • S trong knowledge of primary...Contrato
- For EHS services in the Occupational and Process Safety area. WHAT MAKES YOU A FIT: T he Technical Part: Bachelor’s Degree and or an equivalent of two (2) years of experience in the regulated industry. Bilingual (Spanish and English). Good organizational...ContratistaContratoTrabajo por turnos
- Experience in parenteral products, vision system, device assembly and packaging. Requirements Doctorate OR Masters + 2 years of Engineering experience Alternatively, Bachelor’s in engineering + 4 years of Engineering experience.Contrato
- ...vendor-managed services. · Manage and oversee minor and major deviations, investigations, root cause analysis, CAPAs, and effectiveness... .... · Support implementation and oversight of quality systems associated with cleaning, sanitization, environmental monitoring,...Pago diarioSubcontratista
- ...cleaning development and validation. Perform investigation of deviations / discrepancies. Responsibilities: * Support authoring and... ...support and sample management to cleaning activities associated with the manufacturing process. * Proficient with KNEAT execution...De duración determinadaTiempo completoTrabajo por turnos
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a Sr Associate Deviation Analyst. ¡Sea el primero en aplicar!
