...The QC Associate II will be responsible for the implementation and continuous improvement of QC methods in the production laboratory... ...position you will report to the QC manager.
What You’ll Be Doing
Review and release products based on established QC metrics
Monitor...
Suggested
...cytometry and image analysis
Provide project status reports
Review literature and apply advanced knowledge
Qualifications... ...fluorometer is preferred.
Knowledge and experience with nucleic acids QC instruments is a plus (e.g., BioAnalyzer/TapeStation/LabChip)....
Suggested
Full time
Worldwide
Flexible hours
...talented Quality Control Manager. You will be responsible for leading QC in partnering with CDMOs to meet testing timelines and support... ...CDMO vendors to ensure release testing deliverables are met, reviewing and approving analysis documentation including SOPs
Applying...
Suggested
...transfers, compliance, and scalability for Cellares' Quality Control (QC) operations. This individual will focus on technology transfers... ...with statistical analysis
Responsible for the authoring, review, approval, and oversight of analytical method procedures, method...
Suggested
Flexible hours
...control lab is held to GxP standards and safety standards
* Create, review and approve Certificate of Analysis
* Conduct investigation... ...ensure accuracy and regulatory compliance
* Collaborate with QC Microbiology management in establishing specifications and justification...
Suggested
Contract work
For contractors
Flexible hours
...communication with internal CMC and clinical teams including QA, QC, Regulatory Affairs, Supply Chain, clinical operations to fulfill... ...excellent team player, contributes to project deliverables.
Author, review, and delivers technical documents for regulatory submissions and...
Suggested
Full time
Contract work
Work experience placement
...#hybrid.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s,... ...maintains/ closes out the Trial Master File (TMF/eTMF), perform QC as assigned and resolves discrepancies.
* Maintain and update...
Suggested
Full time
...meetings, including deviation/CAPA, change control, and quality review boards
Establish metrics and report out to management and cross... ...disciplines: API or DP manufacturing, analytical development/QC
Ability to work in a collaborative team environment is essential...
Suggested
For contractors
...Francisco. This position will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This... ...flow cytometry assays, etc.)
Perform timely and accurate peer review of analytical test results/reports
Prepare COA/COT for testing...
Suggested
Flexible hours
...submission documents, responses to Health Authorities questions.
Review and summarize relevant literature on the clinical development... ...queries to sites.
Collaborate with Biostatistics to develop and QC data tables, listings, and figures and develop data-driven study-...
Suggested
Full time
Contract work
...Duties
Responsible for site feasibility and recruitment, including review of Site Information Questionnaires.
Review assigned clinical... ...to management of study vendors.
Assist in performance of TMF QC and reconciliation of findings.
Assists in Investigator...
Suggested
Full time
Contract work
For contractors
3 days per week
...determines risks.
Performs regulatory compliance intelligence review of suppliers.
Responsible for supplier questionnaire management... ....
At least 10 years in quality assurance, manufacturing, QC or quality engineering
Experience in auditing and supplier qualification...
Suggested
Contract work
Internship
Local area
...templates.
Training and mentoring Clinical Trial Associates.
Reviewing protocol/amendment for operational aspects, discrepancies, and... ...of study documents to the TMF including performing periodic QC of assigned sections of the TMF and providing TMF support & guidance...
Suggested
Full time
Remote job
...-based assays following SOP and regulatory guidelines
In volve in assay transfer to other groups, QC, testing group and Research
Participate in writing, reviewing, and editing experimental procedures and reports
Maintain accurate, error-free records of all analytical...
Suggested
For contractors
Flexible hours
Shift work
...comply with relevant regulations.
Partner with analytical and QC to define and execute product characterization, analytical release... ...in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory...
Suggested
Contract work
For contractors
Apprenticeship
Local area
...relationships, and further product understanding.
* Author and review technical development documents and relevant sections of health authority... ..., qualification, and validation activities at external/internal QC laboratories.
Requirements:
* Principal Scientist: PhD in...
Local area
...documentation is critical to success.
Experience in a high-volume manufacturing environment.
Experience with order fulfillment (pick/pack/QC/ship) of custom products is ideal.
Functional knowledge of international shipping, booking shipments, and inventory control....
...Spectroscopy instruments provide scientific insights across a wide variety of applications including pharmaceutical and industrial QA/QC, contaminant analysis, forensic investigation of toxicological substances and trace materials and industrial chemical/polymer...
Holiday work
Temporary work
...Development teams to elucidate structure/function molecular characterization and interact cross-functionally with teams from Discovery, CMC, QC, and more.
Perform potency testing and characterization to support drug development activities and IND submissions.
Qualify/...
...comprehensive study plans
Maintain accurate documentation of experiments in ELN and reports
Work closely with Analytical Operations and QC during knowledge transfer, method transfer and co-qualification activities
Maintain, calibrate, and operate analytical equipment...
Holiday work
Temporary work
Immediate start
...procedures and completes required documentation related to patient x-ray visit.
Maintain all x-ray equipment, including calibration, QA/QC procedures, and record keeping in accordance with current policy and procedures
Medical Assistant Duties
Perform Department of...
Hourly pay
Full time
Immediate start
...CROs to coordinate data and assay transfers, and real time monitoring of assay performance.
* Familiarity with flow cytometry data qc processes.
* Experience with complex data analysis software for flow cytometry such as FlowJo, FCS Express, OMIQ.AI, SPADE, viSNE and...
Remote job
Worldwide
Flexible hours
...including annual and periodic reports.
Responsible for compilation, review, approval and submission of high quality CMC related sections of... ...with SME’s in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain and other business partners. Maintain responsibility...
Holiday work
Full time
Contract work
Internship
Local area
...management framework set by the Head of MAP & Safety Partnering and translates the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.) Works with the Vendor Lead on the oversight of GVP/MAP SPs.
Supports the Vendor Lead on all...
Hourly pay
Contract work
Work experience placement
Local area
Flexible hours
Shift work
...management framework set by the Head of MAP & Safety Partnering and translate the requirements into reporting deliverables (e.g., QA/QC metrics, action items, etc.)
Work with the Vendor Lead on the oversight of GVP/MAP SPs.
Support the Vendor Lead on all operations...
Hourly pay
Full time
Contract work
Temporary work
Local area
Remote job
Flexible hours
Shift work
...collaborating with CROs to coordinate data and assay transfers, and real time monitoring of assay performance
+ Familiarity with data qc processes
+ Experience with complex data analysis software for flow cytometry such as FlowJo, FCS Express, OMIQ.AI, SPADE, viSNE...
Remote job
Worldwide
Flexible hours
...complement internal resources in an innovative and rapidly changing environment.
+ Provide partner training as needed, including data QC and notebook keeping, as well as performing quarterly audits of partner notebook entries.
+ Participate in partner site visits to...
Holiday work
Contract work
Remote job
Relocation
Visa sponsorship
Flexible hours
Shift work
3 days per week
...molecular cloning techniques such as golden gate and Gibson assembly, plasmid DNA preparation, DNA/RNA extraction, cell transfection, viral QC REQUIRED
Hands-on experience with next gen sequencing library preparation and execution including single cell sequencing, and...
Holiday work
Full time
Contract work
Temporary work
Work experience placement
Local area
Shift work
...QC Tech Line Inspector
Manufacturing
Alemeda, CA, US
Pay Rate Low: 20 | Pay Rate High: 22
+ Added - 18/04/2024
Apply for... ...and verify outgoing shipments for accuracy and completeness.
Review and approve labels for production.
Monitor all aspects of the...
Contract work
Immediate start
Shift work
...tactful individual with excellent critical reasoning skills.
Fastidiously detail-oriented and organized, impeccable attention to data QC.
Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and...
Full time
Local area
Remote job
Flexible hours