Realizar limpieza, esterilización, pesaje y dosificación de materiales. Montar e inspeccionar equipos en el área de fabricación para confirmar el estado operativo. Para aplicar, visite nuestra página web o envíe su resume a ******:Grado asociado en Ciencias, Mecánica, ...
...complexity including multiple products at the site and may have the complexity of multiple types of productions (API, Fin Goods, Biologics, Packaging, Device, etc.).
Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance...
...Realizar llenado de jeringas con producto biológico. Limpiar, preparar y esterilizar equipos de fabricación. Para aplicar, visite nuestra página web o envíe su resume a ******:Grado asociado en Ciencias, Mecánica, Electricidad, Instrumentación o campo relacionado. No requiere...
...preferably Microbiology with 2 years of experience in micro testing (ex. bioburden, endotoxins), and microbiology laboratory investigations.
Strong technical writing skills are required, as this resource will support the development and review of l aboratory investigations...
...integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Manage validation related, quality...
...functionally and effective communication within the EHS Department while ensuring that information is timely, clear and accurate.
~ Investigate and prepare required reports of EHS system performance including but not limited to investigation reports, injury reports,...
...how they are applied to regulatory compliance.
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
~Creating long- and...
...business processes, as well as the involved project management.
Job Description
The resource is responsible on managing process investigations, evaluates deviations with respect to their causes and corrective actions to prevent recurrence
Investigations.
Root...
...Compressed Air, and so forth)
~Project Management competencies
~Must be fully bilingual (English / Spanish) with excellent oral skills.
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...The Technical Part:
Bachelor’s degree in Life Science (Biology, Chemistry, Engineering or related EH&S field) and five (5) years... ....
MS Office.
EHS Assessments programs and incident investigations.
Permits and Reports.
The Personality Part:
~ If...
...validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis,... ...position:
• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in...
...change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and... ...Skills:
Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology)
Six (6) years of experience in Quality...
...reports with regulatory agencies.
#Administers the incident investigations program to determine rood cause and develop action plan to avoid... ...Skills and Other Requirements
~Bachelor Degree in Science (Biology, Chemistry, Engineering or related EH&S field).
~Five (5)...
...engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products. To apply visit our site or send your resume to ******:Bachelor Degree in Engineering ( Mechanical, Electrical or...
...engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products.
~Bachelor Degree in Engineering (Mechanical, Electrical or Computer) or Science
~More than Five (5) years in the...
...For Investigations s ervices in the Quality and Utilities area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in Natural Science and at least five (5) years of exposure in Quality activities within the P harmaceutical Industry.
Bilingual (English...
...external trends aligned to corporate strategy. This role will provide strategic HR Business Partner leadership to support the local Biologics Operations Leadership Team, in their execution of the Global Product Development & Supply ("GPS") organization's People Strategy....
...operations areas.
~ Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
~ Provides key technical guidance and oversight to...
...ruggedness and robustness processes.
Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
Coordinates projects to assure...
...Class A or B CDL is required;
Ability to obtain and maintain a Hazmat endorsement required;
College degree in chemistry, biology or other natural science strongly preferred;
Previous experience in hazardous material handling, chemistry and/or lab packing experience...
Clean Harbors
Manatí
Hace 2 meses
...engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products.
~Responsibilities include the Interaction and support using the company standard packaging documentation change control...
..., presentations and reviews data to monitor product processing activities.
6. Leads and participates in out-of-trend product investigations with Senior Product Scientists and represents processing area as requested in fact finding meetings.
7. Leads process robustness...
...opportunities for improvement.
Qualifications Requirements/Knowledge/Education/Skills:
Bachelor's degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry, etc.) or Engineering (Chemical, Mechanical, Electrical, Business Administration) required.
Minimum...
...una red de contactos “networking”, y las siguientes destrezas; de persuasión, de prospectar, de hablar en público, de proceso de investigación, de negociación y cierre, de planificación, de identificación de necesidades del cliente, y de manejo de objeciones. Motivado y...
...Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...related technical discipline.
~At least 5 years experience in the Pharmaceutical Industry; preferably on a sterile drug product or biologics manufacturing site.
~At least 5 years experience in Project Management (PM) with excellent Project Management skills; preferable...
...Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...ruggedness and robustness processes.
#Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
#Coordinates projects to assure...
...services in the Laboratory area
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) and Six (6) years of experience in the Quality Assurance in the industry.
Experience in:
E...
...how they are applied to regulatory compliance.
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
~OOS Lead Investigator...