- Aequor (Thousand Oaks, CA)
- …for role expansion into support of a product distribution function. Skills: ; quality assurance or manufacturing experience in the pharmaceutical industry Must ... duration of the contract. At least 2 years of QA experience in the biotech industry, with a focus...review. Secondary responsibilities will include generation and compilation of quality data and reports (eg lot track/trace, deviations). Individual… more
- Merck & Co. (Durham, NC)
- …Making, General Safety, Good Manufacturing Practices (GMP), Manufacturing Support, Policy Procedures, Quality Assurance ( QA ), Quality Support, Social ... produce life-saving medicines and vaccines, including our HPV vaccines.DescriptionThe Quality Associate Specialist provides guidance/direction on the shop floor… more
- Aequor (Aliquippa, PA)
- …AM to 5:00 PM, Monday-Friday.The ideal candidate will have 5&plus years of QA experience specifically involving raw materials in a GMP-regulated environment such as ... are essential. Avoid candidates seeking remote-only work or lacking QA /GMP/raw material background.Responsibilities: Ensure operations align with applicable regulations… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …participation in relevant training programs.Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.Keep ... properly investigated and that technology-related audits are conducted.Oversee and guide quality assurance processes related to project specifications, ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive ... and compliance related topics including the review of Key Quality Indicators (KQIs). Collaborate with Global QA teams in US, Japan, APAC, Europe and Brazil to… more
- Cytiva (Muskegon, MI)
- …life-changing career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer will be the subject matter expert for ... Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is part of...instructions and cross train as a backup for other QA members.Participate in quality walks and internal… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance , Quality control, and regulatory affairs. In ... validation deliverables associated with various Aurolifesystems such as LIMS, Quality Assurance Management System (QAMS),Waters Empower, Document Management… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …about the Danaher Business System which makes everything possible.The Staff Quality Assurance Engineer or Scientist is responsible for facilitating ... on-site role. In this role, you will have the opportunity to:Representing quality assurance on development teams, quality systems and product improvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance . Overall accountability is develop strategic framework work for ... GxP related functions including at least 5 plus years of experience within progressive GxP- Quality Assurance or equivalentMust have a minimum of 5 years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Confirm final profile and submit in Zycus for SAP creation.As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status ... the inspection. Work with a cross-functional team of Procurement, QA , and Stakeholder Leads to ensure all required vendors...Review and update questions and pending statuses with the Quality Assurance group on a regular basis.Qualifications… more
- Merck & Co. (Rahway, NJ)
- …effective study allocation Take responsibility for any clinical audits, working closely with the Quality Assurance ( QA ) - group and the Good Clinical ... (GCD) regional office. Additionally, there are important interactions with, inter alia , Quality Assurance , Finance, Regulatory, Clinical Supplies and legal in a… more
- Tris Pharma (Monmouth Junction, NJ)
- …(QMS). Title commensurate with experience.Summary:This position supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product ... Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical… more
- Merck & Co. (Rahway, NJ)
- …to deliver objectives.Take responsibility for any clinical audits, working closely with the Quality Assurance ( QA ) group and the Good Clinical Practice ... GCP, local and global policies and procedures to conduct high- quality , inspection ready studies is essential. The position is...studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... English.Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Supplier QualityJob Description SummaryProvide quality assurance services to ensure the integrity of ... manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May… more
- Aequor (South San Francisco, CA)
- …by Roche's clinical trials seamlessly, on-time, and while optimizing cost/ quality . Within Production Enablement, the Global Clinical Materials Manager (GCMM) ... a GMP- and customs-compliant goods receipt dossier for the QA -release of drug products and packaging materials o Request...packaging materials in SAP o Ensure the on time QA -release or AFM ("Authorization for Further Manufacturing") of drug… more
- Merck & Co. (Rahway, NJ)
- …Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study ... and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and reports.… more
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