- Aequor (MA)
- …manufacturing activities. Perform QA review of Executed Batch Records. Perform QA review of Quality Records, ie Deviations, CAPAs, OOS etc., as they occur. ... of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.... trials. Ensure all requirements, stipulated in the CMO Quality Agreements, are being met. Review and… more
- Aequor (Waltham, MA)
- … clinical materials for use in clinical trials Perform lot release Quality Review of manufacturing and quality control records to ensure compliance ... of relevant experience Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) Working...as stipulated in the appropriate QTA, have been met. Issue/ Review documentation, ie Deviations, CAPAs, OOS (out of spec)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or equivalent technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of ... compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP...team, ad hoc, for activities such as annual product review , site risk register, or internal quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... all components of QMS are in place for adequate quality review and oversight.Develop and implement the...in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to 20/30 (Snellen) or betterWorks in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or...1 year of leadership experience is also required.Experience in clinical quality , method development, cell banking, cell… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …10 year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications Experience:10 ... remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Managed Markets, Pharmacovigilance, Supply Chain, Compliance, Quality Assurance , pharma-specific litigation issues, promotional brand review , etc.) ... support to cross functional teams for one or more clinical study programs which may include review ...more clinical study programs which may include review of vendors agreements and policies, external training materials… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Novo Nordisk Inc. (Boulder, CO)
- … Quality Assurance / Control, Chemical Development, Program Management, Regulatory, Quality Control, Supply Chain, and Clinical Write, review , and/or ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... Lead (1st or 2nd shifts) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... all aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification,… more
- MD Anderson Cancer Center (Houston, TX)
- …policies and procedures. . Participate and/or lead departmental clinical research quality assurance initiatives. Review clinical trial documents ... lead for ensuring maintenance of accurate data entry. . Review medical records to extract data points. . Develop...institutional policies and department training. **2. Quality Assurance and Process Improvement for Clinical Research… more
- United Therapeutics (Silver Spring, MD)
- …at our Silver Spring, MD office and 2 days/week work from home. + Develop Clinical Quality Assurance (CQA) Standard Operating Procedures and policies and ... role is responsible for the management and execution of clinical quality oversight activities in support of...managed and/or conducted by Uniter Bioengineering + Develop and review Quality Technical Agreements with critical vendors… more
- Catalent Pharma Solutions (San Diego, CA)
- ** Quality Assurance Associate, Clinical Supplies** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... Catalent Pharma in San Diego, CA is hiring a Quality Assurance (QA) Associate, Clinical ...community engagement. + Defined career path and annual performance review and feedback process. Potential for career growth on… more
- ThermoFisher Scientific (Fishers, IN)
- …the creation of QA reports for regulatory agencies. Prepares annual quality assurance report and submits for review . + Maintains up-to-date knowledge and ... documentation, review of test results, performance and monitoring of quality control, corrective action, proficiency testing, and equipment management as well as… more
- UCLA Health (Los Angeles, CA)
- …challenges and profound rewards. As an experienced CTR, you will perform quality reviews/control on completed abstracts for cancer reporting to the State to ... a 97% or higher accuracy rate, comply with COC Quality Standards, and ensure quality data for...and help train new staff. You will perform periodic review and sampling of abstracts for required accuracy, with… more
- Trinity Health (Fresno, CA)
- …TJC, and state standards/compliance. The incumbent provides technical oversight, data review , mock inspections, and other activities to verify compliance. The ... incumbent is responsible for the Laboratory Quality Management, Performance Improvement, and Patient Satisfaction activities. 1....2. Licensure by the State of California as a Clinical Lab Scientist is required. 3. Five years experience… more
- Adecco US, Inc. (Framingham, MA)
- …respected pharmaceutical company that is now looking to expand their team with a Quality Associate. If you're ready to join a dynamic team, apply today! Benefit ... and Holiday pay upon meeting eligibility criteria. **Job Title** : Quality Specialist II(Pharmaceutical Industry) **Location** : Hybrid, Framingham, MA (Relocation… more
- University of Utah (Salt Lake City, UT)
- Details **Open Date** 10/11/2024 **Requisition Number** PRN40084B **Job Title** PS Quality Assurance Analyst **Working Title** Quality Assurance Analyst ... Posting **Pay Rate Range** $18.41-$26.73 **Close Date** 01/11/2025 **Priority Review Date** **Job Summary** **Job Summary** The Clinical...School of Medicine has an immediate opening for a Quality Assurance Analyst. The Quality … more
