- Aequor (MA)
- …manufacturing documents for the timely initiation of GMP manufacturing activities. Provides Quality oversight and Quality guidance to resolve compliance issues ... for GMID and BOM approval. Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested. Assume additional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission and compliance of all required DS documentation for quality control /assurance, legal, finance, operational and educational requirements.Operates ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...OEDC metrics (ie KPIs, KQIs, and other speed and quality metrics) through the use of dashboards.Coordinates communication of… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Operations, and other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: - ... (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one… more
- Merck & Co. (Upper Gwynedd, PA)
- …overdue CAPA commitments.Assesses and provides input to strengthen company programs/strategies (eg Quality Control Visit (QCV), Headquarters Quality ... clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of...clinical development programs, clinical trial processes as well as quality management systems and quality control… more
- Merck & Co. (Rahway, NJ)
- …Development (AR&D), Design Controls & Risk Management (DCRM), Quality , Regulatory, and Quality Control ( QC ) facilities to ensure that functional testing ... practices.Experience in collaborating with cross-functional teams including AR&D, DCRM, Quality , Regulatory, and QC facilities.Strong project management skills… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shift cleaners to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1st ... 3rd shift cleaning team to ensure facility readiness for manufacturing operations and quality control labs next shift.Communicate with all key stakeholders (MFG,… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control ( QC ), Manufacturing, Operations, Technical Services, ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Merck & Co. (Millsboro, DE)
- …and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Aequor (Newbury Park, CA)
- …coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements. To manage ... for inclusion in US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Risk Assessment plans with milestones and deliverables in collaboration with stakeholders ( Quality , production, engineering, QC and process improvement and R&D ... Therapy Manufacturing Plant. In addition, the candidate must have Quality Risk Assessment experience in the pharmaceutical industry.Primary responsibilities include,… more
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development, validation, and sample analysis project ... Ability to use a variety of computer software Previous GMP/ QC Lab experiences preferred Working EnvironmentPrimarily GMP regulated laboratory environmentRare… more
- BioAgilytix (Durham, NC)
- …a strong working relationship and open communications with all departments, including Quality Control , Quality Assurance and Sample ManagementTrack project ... a strong working relationship and open communications with all departments, including Quality Control , Quality Assurance and Sample ManagementPrepare Sample… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …programs and other materials, including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality ... creation, and marketing execution. Relationships Reports to HCP Experience Lead . Collaborates with key external and internal cross-functional teams, including… more
- Aequor (Bothell, WA)
- …instrumentation as well as site and global applications used within the manufacturing, quality , and quality control organizations. This position requires a ... work assignments as a point of contact for project stakeholders. Lead or provide supporting activities within the quality...support and liaison with global partners for the site quality systems and quality control … more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …clinical and neuropsychological assessments, 3) Analyzing data to assure data integrity, quality control and protocol compliance, 4) Training and supervising ... collection and analysis. Opportunities are also available to become involved in and/or lead research papers and publications. The majority of time will be spent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SOPs, work instructions.Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, Technical ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for ... customers. This position will lead , mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the customer liaison for tech transfer… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a unified and engaging brand/therapy area experience audience Implement rigorous quality control measures for marketing content, ensuring alignment with ... and new product commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development of capabilities to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patient-specific, finished drug product batches by collaborating with all functions (including Quality Assurance, Quality Control , Operations, Vein to Vein, ... to ensure necessary hurdles are cleared for batch release and shipment. Lead cross-functional meetings to provide batch release updates, address challenges and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Manufacturing Operations, Quality Control , and Operations Technical Support. Manage people to support ... requirements in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous improvement efforts, Quality site… more
