1-20 of 20 results
Sort By

- Camarillo, CA

Calibration Technician Tests, calibrates, maintains, and repairs electrical, mechanical, electromechanical, analytical, and electronic measuring, recording, and indicating instruments and equipment for conformance to established standards. Responsibilities: - Performs calibration of equipment as scheduled or as required and maintain records of calibration. - Investigates equipment and documentation out of specification and maintains records. - Inspects parts and equipment to mechanical drawing


The RMA and Document Control Specialist will be responsible for developing, maintaining, and monitoring document control activities per FDA/ISO 13485 and international medical device regulations. The specialist ill be responsible for material returns and repairs for national and international customers by managing the RMA process and resolving customer issues and complaints. In addition, the specialist will prepare/record changes to controlled documents including formatting, review and confirm


The RMA Specialist will be responsible for developing, maintaining, and monitoring document control activities per FDA/ISO 13485 and international medical device regulations. The specialist will be responsible for material returns and repairs for national and international customers by managing the RMA process and resolving customer issues and complaints. In addition, the specialist will prepare/record changes to controlled documents including formatting, review and confirm changes with....


Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials Requirements Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.Ability to travel as required (up to 25%).12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.Industry experience within pharmaceutical....

- Irvine, CA

The candidate will work on a biologics pre-filled syringe product and guide the team with the design controls deliverables by reviewing the plans, protocols, reports, etc., and providing input. The candidate will perform engineering duties associated with the design, research, and development of combination products. RESPONSIBILITIES: Review all development documentation generated in projects. Provides technical assessments for business development decisions as needed. Provides technical....

- Gaithersburg, MD

The candidate will be a part of the drug delivery and device development group responsible for combination product development involving parenteral injection devices delivering biologics and peptides. Responsibilities: Leads platform device projects as a technical team lead. Responsible for all the device deliverables to support combination product development. Design concepts and generate creative device features to best meet user requirements. Oversee engineering tests for design....


This is for an apprentice position. The candidate for this position is one that is at the beginning of their career or who is learning a new trade. Responsibilities Managing project plan for assigned product launchFacilitate launch planning process for assigned productEnsure completion, accuracy and timeliness of key deliverablesGenerate periodic status reportsPlanning, Executing, and Closing ProjectsBuilding its comprehensive work planManaging the risks, issues and changes on the project....

- Irvine, CA

The Quality Control Associate is responsible for performing hands-on quality related tasks to fulfill QA/QC support for implementing and maintaining QMS compliance as directed by management. This position is responsible for supporting and maintaining quality systems and functions within the company. RESPONSIBILITIES: - Participate in developing, reviewing and maintaining documents to include corporate level Standard Operating Procedures to ensure quality objectives are met. - Inspect finished....


Responsibilities: Manage project plan for assigned product launch which include working with the project team to create the project plan Set timelines, track milestones, and forecast budgetary and resourcing needs until plan completion Facilitate launch planning process for assigned product Build meeting agenda and conduct project meetings Review project plan periodically with the project team Ensure completion of assigned action items and deliverables in a timely manner Qualifications:....

- Cleveland, OH

The Document Control Specialist will be responsible for developing, maintaining, and monitoring document control activities per FDA/ISO 13485 and international medical device regulations. The specialist will be responsible for material returns and repairs for national and international customers by managing the return merchandise authorization process and resolving customer issues and complaints. In addition, the specialist will prepare/record changes to controlled documents including....

- San Fernando Valley, CA

Seeking a candidate to organize and coordinate new site recruitment as well as create and implement unique Pharma studies. The candidate will work closely with the Medical Director to select new sites to join our growing USA and International network as well as develop and implement original studies and help seek Pharma sponsorship. The candidate will maintain high levels of organizational effectiveness and communication. Our ideal candidate will be able to manage multiple sites for....


The Clinical Trial Data Analyst is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other sources. In addition, the position coordinates in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. Responsibilities: Prepare data reports, tables and graphs for regulatory submissions, IRB submissions,....


This position is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk-Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must be able to lead data review activities and engage different


Education/ExperienceBS in life sciences or related field At least 2 years experience in clinical researchKnowledge of FDA regulations Prior Study Start-Up experience preferredAdvanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plusPresentation Delivery ResponsibilitiesExecute study start-up for assigned protocols within company timelines by identifying clinical team needs, Oversee Site....

- Irvine, CA

The candidate is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.The Master Specifications and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing),....


The specialist will work with a team of medical information professionals to capture unsolicited medical inquiries from health care professionals, consumers, and corporate business partners. Also, research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database (product label, published and unpublished studies) to develop a medical/scientific response that is accurate, fair balanced, complete and delivered in a....


The Associate will be responsible for supporting CTM/OSL and ensuring that all assigned clinical study(ies) are running on time and on budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. Requirements: Bachelor’s degree or higher (science degree preferably in science or health-related field) Previous experience of working on a clinical study 1-2 year relevant experience in pharmaceutical industry or CRO....


EDUCATION/EXPERIENCE: - 1+ years of relevant experience in pharmaceutical industry - Science degree in medical or health-related field - Clinical Trial Support/Clinical Study experience - Work effectively in a team/matrix environment - Handle conflict management and resolution RESPONSIBILITIES: - Ensuring that clinical studies are run on time and budget - Ensure compliance with regulatory guidelines - Management of clinical trial documentaiton - Tracking of various clinical trail resources


The Quality Engineer will be responsible for participating in risk management, design and process control activities per FDA/ISO 13485 and international medical device regulations. The engineer will provide technical support in development, maintenance and improvement of all quality systems. Responsibilities: Design control including DHF, DMR and technical files Assure that all product requirements, risk management, verification and validation activities are properly addressed and documented....

- Menlo Park, CA

Phase I company needs a Clinical Trial Manager/Clinical Project Manger to manage the day-to-day operations of the company’s cell-therapy clinical trials and associated projects. Company is open to W-2, contract and contract to hire. This position is onsite at the company HQ in Menlo Park, CA. Qualifications5+ years of experience in clinical research and/or clinical trial operations with a strong track record of successful trial initiation and execution. Sponsor (industry) organization....

1-20 of 20 results