- Merck & Co. (Rahway, NJ)
- …SOPs to ensure practices are accurately reflected. Assist in SOP and quality -related system document approval. Support metrics by summarizing findings during ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am ... They will work closely with cross-functional teams and within document control and overall quality department to ensure the changes are accurate and are… more
- Merck & Co. (South San Francisco, CA)
- …the review process. -Implement strategies to leverage GenAI for improving document quality and consistency.Education Minimum Requirements: -Ph.D. in Computer ... focused on bringing AI/ML approaches to bear to improve the speed and quality of decision-making in drug discovery and development. PDMB aims to leverage Generative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit activities per audit program of GxP ... the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common...least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and ... collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier… more
- Twist BioScience (South San Francisco, CA)
- …including Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) ... and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need Perform other duties & projects as… more
- Formation Bio (New York, NY)
- …best practices. Implement data validation and observability frameworks to ensure quality , trust, and reproducibility of datasets. Document transformation logic, ... infrastructure, and generative AI. While your initial focus will be on building high- quality EHR models for Formation Bio platform, you'll also contribute to our… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a QC Inspector I to join our growing Quality Department team in Hopkinton, MA for 2nd shift operations (M-F).The QC Inspector I will report ... position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for inspecting, auditing and reporting… more
- Aequor (East Syracuse, NY)
- …validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc. Strong ... and downstream manufacturing process development, characterization, and process improvements. Document and evaluate experimental results and perform data verification… more
- Merck & Co. (Rahway, NJ)
- …data models, and BI artifacts to ensure collaboration and code quality .Experience leveraging Databricks for big data processing, advanced analytics, or machine ... insights.Ensure data accuracy, consistency, and security across all BI solutions. Document processes, data models, and solutions; provide training to end-users… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Validation Specialist role is ... an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.The Sr. Specialist, Calibration… more
- Merck & Co. (Upper Gwynedd, PA)
- …communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership as needed in product ... pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance, n ovel modality and technologies such as synthetic… more
- Merck & Co. (Rahway, NJ)
- …on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and ... and Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews… more
- Merck & Co. (Durham, NC)
- …sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times, ... and approve out of tolerance (OOT) records and ensure quality notifications follow when required.Facilitate scheduling of calibration activities with… more
- Merck & Co. (Boston, MA)
- …to collaborate across departments to ensure awareness and access to high- quality information that drives scientific discovery and innovation.- The ideal candidate ... accordinglyStaying current with emerging pharmaceutical information tools and databasesSupporting document delivery requests and end-user requestsObtaining journal articles and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. ... Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers.Ensure ... adequate training of resources to enable quality of deliverables. Manage quality , efficiency, and resources for PV service providers/vendors.Measure and monitor… more
- Repligen (San Diego, CA)
- …of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The Laboratory Support Specialist will provide support both at ... the CTI/Repligen Sales Force with testing, reporting and customer interactions. Document activities on the CTI/Repligen CRM software platforms & deliver… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and manual staining and other duties associated with production of high- quality microscope slides (including finding challenging targets in certain tissues/organs). ... the ability to follow written standard operating procedures and the ability to document work in accordance with Good Laboratory Practices (GLP). Must also be able… more
