Resultados de la búsqueda: 31 vacantes
...required to carry out.
Monitors operator training files and works with compliance specialist to keep files up to date.
Works with QA and Subject Matter Experts (Tech Ops or Process Sciences) to resolve exceptions.
Works with technology transfer team to...
...Engineer or formal training in quality engineering or statistics is preferred
~15+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
~ Must have a basic understanding and working knowledge of the physical...
...to ensure proper utilization of MES and EBR systems and adherence to established procedures.
Collaborate with Quality Assurance (QA) and Regulatory Affairs teams to ensure compliance with relevant regulatory guidelines, such as FDA 21 CFR Part 11.
Implement data...
...immediacy of supervision:
• Working relationship with unit’s members and unit Teams from other disciplines (Engineering/Maintenance, MS&T, QA/QC, LOSM, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
CONTACTS Describe the...
...Policies.
#Provides support to the area QA Leader during the budget preparation activities... ...level criteria when additional or special testing is required.
#Performs trend analysis to... ..., inconsistencies and interpret sampling test results
~Proficient knowledge of problem...
...CAPAs. A minimum of three (3) years of experience managing direct reports.
Experience in pharmaceutical/biotechnology operations , QA or technical support is necessary to successfully perform responsibilities of the position.
Advanced technical writing skills...
...Monitoring clean utilities
~ Monitoring to freezers
~Monitoring, operation and repair of drinking water system
~ Water chemistry tests
~Execute preventive maintenance, troubleshooting and general repair work on specific assigned working area/site of mechanical,...
...and data mappings for new systems aligned with site Data Integrity master Plan and applicable processes and procedures.
Develop test scripts to confirm the computerized systems are in compliance with data integrity requirement, User and Design Specification requirements...
..., YOU WILL: (The day-to-day on the job)
Conduct process equipment installation/operational/performance qualification studies to test their functionality.
Prepare operational qualification assessments to support that validated critical operating parameters are within...
...markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Analyze test results, machine error messages, and information obtained in order to diagnose equipment problems.
Clean, lubricate, and adjust...
...existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method.
Supports technical aspects of test method ruggedness and robustness processes.
Supports the Analytical Ruggedness Project Manager and Quality Control to gather information...
...Improve inspection processes, technologies, and systems to ensure compliance with drug quality and cost specifications.
Write test procedures, inspection machinery specifications, performs line trials and troubleshooting, work with inspection technology machinery...
...commitments over this horizon. Details of activities include key NPI launches, projects that support overall plant efficiency improvements, test method transfers , and future strategy and vision development.
Responsibilities
Lead all aspects of NPI projects from...
...drywall and wood trim repair, light bulb and A/C filter replacement and the complete and thorough cleanup of the painting or repair area. Test, troubleshoot and perform basic repair on all types of equipment, plumbing (e.g., plunge toilets and unclog drains), electrical...
Marriott International
Dorado
5 días atrás
...procedural requirements and scientific principles. Performs laboratory testing within a GMP environment in support of one or more of the... ...changes to maintain procedural requirements.
Performs analytical test methods as written to support product/material release with...
...job)
Improve packaging processes, technologies and systems to insure compliance with drug quality and cost specifications.
Write test procedures, packaging machinery specifications, performs line trials and troubleshooting, works with packaging machinery vendors,...
$20 - $27 por hora
...Conduct comprehensive time studies on manufacturing processes to identify bottlenecks, reduce waste, and increase efficiency.
Design, test, and implement lean manufacturing techniques to optimize production flow and minimize production time.
Collaborate with cross-...
...biomolecules.
#Experience designing, executing and evaluating method development protocols for new and existing methods.
#Proficient in test method and processes.
#Technical knowledge with experience in biomolecules method optimization and troubleshooting.
#Broad...
...presentation standards, and food preparation checklist. Prepare cold foods. Operate ovens, stoves, grills, microwaves, and fryers. Test foods to determine if they have been cooked sufficiently. Monitor food quality while preparing food. Set-up and break down work station...
Marriott International
Dorado
5 días atrás
...:
E xperience related to a Laboratory equipment qualification documents development, execution and report as well as laboratory test method creation and configuration in the applicable instrument software.
Regulations (Risk Assessment, Data Mapping etc.), EU regulations...
