...Impact:
Support implementation and management the Maze Quality Systems including document control, change management, deviation, investigation/CAPA, training, and vendor management
Support implementation and validation of an eQMS system for document management,...
Suggested
Holiday work
...subject matter expert and provide guidance and training on quality events, including but not limited to change control, deviations, investigations, and CAPAs
Establish and implement risk management program
Own and drive completion of Quality Systems deviations,...
Suggested
For contractors
...appropriate departments, ensuring all paperwork is accurate etc.
Revise SOPs, performs risk assessments, initiate deviations, perform investigations and CAPA
Additional duties as assigned
Requirements
~ High School Diploma or GED
~5+ years of industry experience...
Suggested
Full time
Worldwide
Flexible hours
...operating procedures and work instructions
Develop and manage manufacturing documentation framework/templates
Investigate nonconformances and deviations at component and subsystem level Initiate and process engineering, document, and ERP system changes...
Suggested
Contract work
Flexible hours
...and safety standards
* Create, review and approve Certificate of Analysis
* Conduct investigation regarding out of specifications (OOS) results and address and manage deviations related to analytical procedures
* Review and approve data to ensure accuracy and regulatory...
Suggested
Contract work
For contractors
Flexible hours
...regulations, and SOPs. Your primary role involves oversight of CRO investigative site management activities from the Sponsor perspective (ie,... ...addressing safety related questions.
Ensuring protocol deviations are appropriately classified and documented, and followed-up...
Suggested
Full time
Remote job
...results/reports
Prepare COA/COT for testing performedIdentify discrepancies, initiate and investigate OOS/OOT results for phase 1 and phase 2
Initiate and investigate deviations related to quality control
Compile and review data to ensure accuracy and regulatory...
Suggested
Flexible hours
...development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA... ...resolution; ensure consistent, quality data review, protocol deviation review, and coding review.
Identify clinical data trends;...
Suggested
Full time
Contract work
...expected to precisely follow written procedures, practice sterile technique,
demonstrate accurate documentation skills, and report deviations in a timely manner. They should
be able to work independently within guidelines and policies, with minimal guidance....
Suggested
Hourly pay
Full time
Contract work
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours
...and characterization of small molecules as a part of process investigation, quality by design (QbD) process development, and optimization... ...cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, and validation protocols...
Suggested
Contract work
...molecularly targeted radiotherapy product manufacturing, packaging, and distribution.
Manages and oversees change controls, deviations/investigations, CAPAs, vendor qualification, customer complaints, stability studies, regulatory agency inspections, product recalls, and...
Suggested
Apprenticeship
Local area
...up by stakeholders. s. Maintain food safety scorecard metrics and report trends to stakeholder. Manage incident reports to track deviations and ensure appropriate follow-up and corrective actions.
•Oversee Batch Manufacturing Records review and manage Hold and Release...
Suggested
Hourly pay
Work alone
Shift work
Weekend work
...Be Doing
Review and release products based on established QC metrics
Monitor QC data
Investigate product/process/quality issues
Review of CAPAs, process deviations, root cause analysis
Preparation of product and process quality reports by collecting, analyzing...
Suggested
..., vendor requirements, etc.)
Perform and oversee study monitoring activities, including review of monitoring reports, protocol deviations, and data listings to ensure data quality.
Manage operational aspects of clinical studies from study start-up through database...
Suggested
...AND RESPONSIBILITIES
Collaborate with Quality, Study Team, investigational sites, and clinical service providers to provide clinical... ...operations staff.
Lead investigations into compliance issues, deviations and complaints, and implement corrective and preventive...
Suggested
Full time
...and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications including auditing... ...Alumis products including collaborations on complex investigations.
Attend and support quality system and product review meetings...
Contract work
Work experience placement
...accurate and detailed documentation of all work produced in batch records, databases or other acceptable formats including problems and deviations
Updating and writing work instructions and documentation
Ability to work independently and in a safe manner
Attention to...
Flexible hours
Shift work
...and are defect-free. Coordinate with users to facilitate user acceptance testing.
Carry out root cause analyses in the event of deviations and develop solutions and tracking.
Provide training and support to end-users on SAP functionality and enhancements. Develop...
Interim role
...clinical documents, including but not limited to study protocols, investigator brochures, informed consent forms, case report forms, and... ...trials. Identify and address data discrepancies and protocol deviations in a timely manner.
Site Staff Training: Provide training...
Contract work
Temporary work
Interim role
Remote job
Flexible hours
...sourcing & planning of maintenance/calibration activities
Investigate and document new sources for equipment, tools, programs or... ...maintenance/calibration/replacement of assets
Document deviations to standard sourcing, planning, and sourcing issues and solve...
Local area
...multiple projects and samples, maintain thorough, accurate and detailed, documentation of all work produced including problems and deviations
What You’ll Bring to the Team
Bachelors/ Associates degree in biology, chemistry, biochemistry
Strong background and...
...development and implementation of Clinical Affairs SOPs
Responsible for core eQMS processes such as CAPAs, change controls, deviations, CAPAs and Training documentation.
Evaluate quality events, incidents, queries and complaints to support CMC and clinical affairs...
Contract work
Flexible hours
...position which, under the guidance and supervision of the Principal Investigator (PI) and clinical trials administrative management, assists... ...required in the protocol, and report all protocol violations/deviations and averse events to the PI in a timely manner to ensure the...
Hourly pay
Full time
Work experience placement
Local area
Shift work
...expected to precisely follow written procedures, practice sterile technique,
demonstrate accurate documentation skills, and report deviations in a timely manner. They should
be able to work independently within guidelines and policies, with minimal guidance....
Flexible hours
...achieve optimal patient care across the continuum. Researches, identifies, and implements best practice models of other units. Investigates and resolves patient/family member concerns regarding patient care.
Kaiser Permanente conducts compensation reviews of positions...
Hourly pay
Local area
Relocation bonus
Shift work
...purpose logistics network
•Stay current with changes in logistical needs
•Keep current on industry trends and market conditions; investigate and implement innovative and value-added services
•Closely partner and collaborate with 4PL provider and internal stakeholders...
Hourly pay
Full time
Contract work
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours
...Develop new business and analyze current clients logistical problems and produce innovative solutions
Address customer complaints, investigate root cause for product issues at origin or upon arrival at destination
Host customer visits as necessary
Additional tasks...
Holiday work
Offshore
Flexible hours
All shifts
...spheroids for supporting our drug discovery programs.
Makes detailed observations, analyzes data and interprets results.
Investigates, creates and develops new methods and technologies for project advancement.
Our Client
Our client is an award-winning...
...Provide periodic updates via email, in-person and/or zoom with regards to project milestones, schedule, budget, and deliverables
Investigate and resolve problems, identifying root cause, and propose process improvements through clear communication with internal teams...
Flexible hours
...processes and materials.
Document detailed observations of experiments, record data and assist with the analysis of results. Identify deviations with experiments and seeks appropriate advice to resolve.
Write test protocols, SOP's and reports.
Work within a cross functional...
Temporary work
Shift work
Monday to Friday