...seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
~Document Control Representative
The Document Control Representative will play a critical role in maintaining and organizing documents,...
...The Technical Part:
Bachelor’s degree in engineering or science. • Training in validation methodologies, technologies and process control computer systems. • Five (5) years of experience in computerized system validation of pharmaceutical or biopharmaceutical industry....
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment's, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and...
...technical aspects of test method 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....
...Provides technical and regulatory guidance on environmental programs, focusing on recognizing, evaluating, and controlling environmental hazards. To apply visit our site or send your resume to ******:Bachelor Degree in Science (Biology, Chemistry, Engineering or related...
...#Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.
#Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving skills.
#Willing to work irregular hours, rotative shifts...
...environmental programs, focusing on recognizing, evaluating, and controlling environmental hazards.
~ Advice management on the proper... ...environmental sampling, reports monitoring results, and recommends control measures to management.
~ Oversight the operation of the...
...overall inspection certification program, personnel certification, new inspection methodology, inspection test set maintenance and control.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important...
RESPONSIBILITIES
Accountable for timeliness statistical analysis and trending of product batch data to ensure process control and capability and; for product robustness analyses through the overseeing, coordination support, collection and monitoring of product batch information...
Additional Information $14.88 p/h
Job Number 24065589
Job Category Rooms & Guest Services Operations
Location Dorado Beach a Ritz-Carlton Reserve, 100 Dorado Beach Drive, Dorado, Puerto Rico, United States VIEW ON MAP
Schedule Full-Time
Located Remotely...
...Biologics products.
~Responsibilities include the Interaction and support using the company standard packaging documentation change control system.
~This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good...
...decisions and developing recommendations. Limiting factors might include existing policies, procedures, laws, regulations, internal controls, etc.:
• The incumbent is responsible for the day-to-day decision making on technical matters related to troubleshooting,...
...and approves all equipment, utilities, facilities, process, product and computer systems validation protocols and reports, change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology...
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell...
...overall inspection certification program, personnel certification, new inspection methodology, inspection test set maintenance and control.
Minimum Requirements:
~Bachelor Degree in Sciences or Engineering (Mechanical, Electrical or Computer).
~Five (5) years in the...
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment's, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and...
...extended hours, possibility of weekends and holidays.
Responsibilities:
~OOS Lead Investigator for utilities, facilities and pest control
~Risk Assessment Review
~Site Deviations Support
~CAPA support
~SOP Revisions
~Forms optimization project
~Change Control /...
...potential roadblocks and proactively resolves problems.
~Direct project correspondences by preparing and reviewing project proposals, memos, meeting minutes, change controls and emails; as applicable.
~Motivating people involved in the project to complete tasks on time....
...environmental programs, focusing on recognizing, evaluating, and controlling environmental hazards.
#Advices management on the proper... ...environmental sampling, reports monitoring results, and recommends control measures to management.
#Oversight the operation of the Waste...
...for documentation, materials, training and equipment modifications.
~Supports establishment of process monitoring parameters and control limits.
~Supports the assessment of deviations and process monitoring data
~Monitors and evaluates parameters in existing (on-going...
...provide lot disposition recommendation when an investigation is completed as needed.
#Manages audit observation, investigations, change control and CAPAs records in applicable QMS on timely manner.
#Provides technical guidance and quality assurance support in the transfer...
...Se solicita Vigilante de Seguridad para urbanización con acceso controlado. Entre las tareas se encuentra: Recopilación de información de visitantes, Rondas en facilidades recreativas, recibir a proveedores de servicios, entre otras. Puede enviar su resumé a ******:Debe...
...biologics manufacturing, especially with experience in quality systems (being able to own or assess the impact for change plans/change control), and product transfer.
• Must have experience in Tech Transfer and Process Support for biologics manufacturing.
• Must have...
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell...
...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipment , tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and...
...Identify and evaluate equipment enhancements to support intended qualified operational ranges.
Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications....
...procedures for transfer to manufacturing operations.
Develop manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
Ensure processes and procedures are in compliance with regulations...
...repairs or upgrades.
Handle routine landscaping and groundskeeping tasks, including mowing and snow removal.
Monitor and maintain security systems, alarms, and access controls.
Respond to emergency maintenance requests, including after-hours and on weekends....
...related field.Experience in biologics manufacturing, especially with experience in quality systems (being able to own or assess the impact for change plans/change control), and product transfer.Experience in Tech Transfer and Process Support for biologics manufacturing....
...presence to monitor the progress of project activities, review status of work completed during the period covered, including quality control.
Ensures that all planned work is generally proceeding well and in accordance with approved drawings and specifications, and...