- Repligen (Waltham, MA)
- …issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering , ... of experience in supplier quality engineering , manufacturing engineering , or quality assurance . Proven experience with ISO 9001 audits and supplier… more
- Aequor (Thousand Oaks, CA)
- …graduates without industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily ... The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve… more
- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a ... with SAS and Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical… 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
- Merck & Co. (Rahway, NJ)
- …members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities are conducted with the ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering , Biomedical… more
- Repligen (Hopkinton, IA)
- …and make real-time adjustments to meet production targets.Inspect products for quality assurance and report defects or inconsistencies.Communicate effectively ... with supervisors and other departments (maintenance, quality , engineering ).Assist with scheduling, timekeeping, and attendance tracking.Identify and report… 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
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Merck & Co. (Upper Gwynedd, PA)
- …related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such ... an unwavering focus on complianceEducation Requirements: BS in a biological science, engineering , or a related field (advanced degree preferred). Fields of study… more
- Aequor (Thousand Oaks, CA)
- …management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained ... value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering . A high...Development, Supply Chain, Quality , and Facilities & Engineering . A high degree of interactions and collaboration is… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance , and manufacturing ... judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget.Update group members on background and… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering , Supply Chain, etc.).-At least… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... Skills:Accountability, Accountability, Assembly Operations, Batch Processing, Batch Production, Chemical Engineering , Communication, Driving Continuous Improvement, GMP Compliance, Good Manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the… more
- Merck & Co. (North Wales, PA)
- …requirements - ** Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge ... in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical… more
- Sartorius (Ann Arbor, MI)
- The Sartorius Lab Products and Services (LPS) team is seeking an experienced Software Quality Assurance Engineering Manager to lead our software development ... with us: + Develop and implement quality assurance practices and standardized processes across the engineering... assurance practices and standardized processes across the engineering team to improve product quality , enhance… more
- AIG (Charlotte, NC)
- …technology risk and compliance. How you will create an impact The Director GI International Quality Engineering & Assurance is critical to the success of the ... management capabilities is required to have a deep understanding of Quality Assurance and Engineering (QA&E) practices and principles, solutions, frameworks… more
