- Aequor (Seattle, WA)
- Job Description: Job Title: Quality - Business Systems Analyst Location: Seattle, WA *Hybrid OR 100% Onsite* *Need 2* Top Skills: - SAP analyst with some IT ... therapy / Biotech exp. preferred Overview The SAP S4/Hana Business Delivery Lead Systems Analyst is a service oriented, positive, forward thinking team member, who… more
- Aequor (Salt Lake City, UT)
- …knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems , as well as Quality systems such as Trackwise. Self-directed ... Job Title: Quality Analyst IIILocation: Salt Lake City, UTLong term...have to be considered for the role: Performed QA review /approval of non-complex investigation reports, change controls, Standard Operating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … of testing.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …personnel. The successful candidate will provide technical expertise in validation, quality systems , deviations, change control, equipment qualifications, and ... degree in science, engineering, or related discipline5 years of experience with Quality Systems , GMPs, and regulations in a manufacturing environmentExperience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and control access to any systems used to support audits/inspections.Provide support to quality systems team, ad hoc, for activities such as annual product ... review , site risk register, or internal quality ...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.RequirementsA minimum of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …available for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all ... regulatory submissions and / or inspections Ensures that appropriate systems , processes are in place to enhance GLP/GCLP activities...components of QMS are in place for adequate quality review and oversight.Develop and implement the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …master documentation. This position will additionally serve as a final Quality Reviewer /Approver for internal documentation. The Documentation Control Supervisor ... only made available to necessary personnel.Serves as the final Quality Reviewer /Approver for internal company documentation [e.g.,...and three (3) to five (5) years in the Pharmaceutical Industry, preferably in a Quality Systems … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SOP's and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as ... is preferred.People management or leadership experience is required.Experience working with Quality systems is required.Experience with quality support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …printed labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems , batch records and SAP. Work in a team based, ... inspections and audits as needed.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements, as well as according to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive continuous improvement.Have advanced computer ... is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA...to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneouslyPerform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Manufacturing Excellence Manager… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation of testingPerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsOther duties will be assigned, as ... communicate key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory dataUtilize electronic systems (LIMS) for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend ... to the system and information to do that work.- Review the QA onboarding business slides edits and updates...experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation of testing.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as ... communicate key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and WI'sPerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsRequirementsBachelor's Degree in Science, Engineering ... Biotech is seeking QC Analyst as part of the Quality team based in Raritan, NJ. Role OverviewThe QC...final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory dataUtilize electronic systems (LIMS)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of their trainings / qualifications, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support in daily completion of QC ... of multiple myeloma.Legend Biotech is seeking a QC Technical Traineras part of the Quality team based in Raritan, NJ. Role OverviewThe QC Technical Trainer is an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management systems ... or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance ... and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and HEPA certification experience Proficient use of Asset Management and Quality Systems Strong understanding of industrial instrumentation HVAC, and ... work in a team environment Must have the ability to author and review accurate and effective Standard Operating Procedures or work instructions Proficient with… more
- BioAgilytix (Boston, MA)
- …need them.BioAgilytix is seeking a detail-oriented and proactive GxP Laboratory Systems Administrator to suppport the administration, development, and deployment of ... our laboratory systems . This role plays a critical part in supporting...functional subject matter knowledge for the assigned applicationsCollaborate with Quality on initiatives and projects related to system implementation… more
