- BioAgilytix (Durham, NC)
- …a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build ... meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial ...status, religion, age, disability, gender identity, results of genetic testing , service in the military, or any other group… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of external data -- acceptance, storage, and delivery activities to ensure complete, high- quality data is available for use by clinical study teams in a ... continuous process improvements and other initiatives.Proactively identifies and manages risks to data quality , data integrity, programming and reporting… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance and Instrumentation Technician is responsible for providing equipment troubleshooting ... an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.-Under the supervision… more
- Merck & Co. (Durham, NC)
- … review and run reconciliation activities as required (ie, UV and FIT testing ).Perform Quality retain sample management activities. Lead housekeeping and ... hands-on approach to problem solving, and be self-motivated to identify and lead process improvement projects.The Quality Assurance Specialist provides support… more
- Merck & Co. (Millsboro, DE)
- …(freeze-drying) capacity being built at the site.This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial ... manufacturing judgment. You will lead technical strategy, science-based technology transfer and scale-up of freeze-drying and fill-finish processes for vaccine and… more
- Formation Bio (New York, NY)
- …with internal and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review and ... approval of batch records, release testing , and other quality -related documentation. Foster a culture of continuous improvement and development within the … more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join ... at the device component/ subassembly/ in-process material and combination product level. Lead stablishing test methodologies/ testing readiness and execution in… more
- Cipla (Hauppauge, NY)
- …knowledge of instruments such as Karl Fisher, HPLC, GC, Particle size, ICP Lead investigation activities. Ensure compliance to all data integrity and cGMP ... Job Title: Quality Control (QC) Chemist III FLSA Classification: Full-Time,...is simply described as an individual contributor who performs testing of samples of various types using various techniques… more
- Insmed Incorporated (NJ)
- … data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across Insmed's technology landscape ... and protect sensitive patient and research data .Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech, or… more
- Merck & Co. (North Wales, PA)
- …patients, partners, and colleagues.As a Technical Product Manager for the Compliance, Risk, Quality , & Vendor Management product you will spend a lot of time helping ... IT applications. You will work side by side with Product Line Lead , Software engineers, Architects, UX designers, Business Analyst, Technical Project Manager,… more
- ValSource, Inc. (Rahway, NJ)
- …currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting ... ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various client… more
- Cipla (Fall River, MA)
- …Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards. Identify and resolve operational inefficiencies, escalating complex issues ... non-conformances, and CAPAs (Corrective and Preventive Actions). Work closely with Quality Assurance (QA) to ensure adherence to standard operating procedures… more
- Cipla (Fall River, MA)
- …First Shift: 07:00AM - 03:30PM (May vary based on business needs) Reports To : Quality Assurance Manager Salary Range : $21 - $26 PURPOSE The purpose of the QA ... Manufacturing Inspector position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with… more
- Merck & Co. (Durham, NC)
- …an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.-Under the supervision ... of the Maintenance Manager and/or Lead , the selected candidate will utilize strong knowledge of...this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests.-… more
- Cipla (Fall River, MA)
- …functionality of all the equipment and associated controls during the batch run. Act as quality lead for all shop floor questions / concerns. Backup for shop ... Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional,...Review of engineering records such as temperature and humidity data calibration and PM records, pest control records and… more
- Merck & Co. (Rahway, NJ)
- …skills, demonstrated creativity, effective interpersonal and collaborative skillsDemonstrated ability to lead teams to deliver high- quality results against firm ... this role, the Director of the Raw Materials and Medical Devices will lead a team of approximately 10 specialists and scientists supporting excipients, package… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... activities for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification of complex systems.-The… more
- Merck & Co. (Rahway, NJ)
- …Change Management, Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, Design Verification Testing , Distribution ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution… more
