- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product release practices.Develop positive relationships with the QA team, Quality Control , Information Technology, maintenance, Manufacturing personnel, ... quality and compliance input for continuous improvement; and remediation's. Lead continuous improvement projects to reduce turnaround time for batch review… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required ... teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming… more
- Aequor (Devers, TX)
- …improvement of process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT systems ... The Sr. Director, Cell Therapy Devens Manufacturing Site IT Lead position plays a critical role in managing all...technical operations environment. Experience should range from manufacturing and quality control systems to GxP quality… 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
- Genmab (Plainsboro, NJ)
- …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Genmab (Plainsboro, NJ)
- …integrity, consistency, and adherence to standards, and ensuring well-structured, high quality data summaries for internal decision making and reporting to health ... within a clinical study, depending on background and experience.As a lead , reviews CRFs for adequacy and consistency.Supports the establishment and maintenance… 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
- Merck & Co. (Rahway, NJ)
- …the CDT Program Manager will be involved with the creation and execution of Quality Control and User Acceptance Testing procedures for electronic data capture ... person should implement changes as appropriate.May be assigned to lead or participate in cross functional technical and/or process...as needed to the staff.May be assigned to a lead role for larger, and more complex or higher… more
- BioAgilytix (Durham, NC)
- …as needed.o Collaborate with cross-functional stakeholders, including lab operations, IT, and quality control teams, to prioritize and address business needs in ... compliance with laboratory standards. Instrumentation Integrationo Serve as the technical lead for integrating both simple and complex lab instruments with… 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 ... documentation practices.Ability to check and respond to the BMS/EMS alerts.Understand quality systems to include; Change Control , Deviations, CAPA's,… 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
- 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
- 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
- CHRISTUS Health (Alamo Heights, TX)
- …and upkeep of the unit supplies and equipment. Maintains and ensures documentation of quality control aspects of the clinic(s) (eg POCT logs, refrigerator temps, ... administrators, patients, families, other departments, and the community to provide quality patient care and enhance patient outcomes. Maintains core staffing within… more
- CHRISTUS Health (Tenneryville, TX)
- …upkeep of the unit supplies and equipment. * Maintains and ensures documentation of quality control aspects of the clinic(s) (eg POCT logs, refrigerator temps, ... patients, families, other departments, and the community to provide quality patient care and enhance patient outcomes. * Maintains...Oversees daily staffing of the unit and collaborates with Lead Associates on the development and revision of the… more