- Repligen (Waltham, MA)
- …with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve as ... This leader will be responsible for managing the site quality assurance team which includes all day-to-day...experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years… 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
- Eisai, Inc (Exton, PA)
- …collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... company's discretion.9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development , Quality Assurance , Quality Control,… 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 ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Eisai, Inc (Raleigh, NC)
- …Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with ... Records (MBRs)Assist with entering events, change controls, and complaints into quality management system.Conduct ongoing tracking, documentation, and reporting… 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
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development , and Regulatory Affairs ... MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the… more
- Merck & Co. (North Wales, PA)
- … conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Aequor (Houston, TX)
- …and knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate ... M-F 1st Shift on-site 5x/week Responsible for tracking, management , and completion of Supply Chain Quality...to work well within a team. Routine interaction with Quality Assurance and other Quality … more
- Merck & Co. (Rahway, NJ)
- … Management Process, Management System Development , Problem Management , Quality Assurance (QA), Resource Planning, Service Delivery, SLA ... Management , Software Configurations, Software Development Life Cycle (SDLC), Stakeholder Communications, Strategic Planning, Strategic Thinking, Testing {+ 1… more
- AUROBINDO (Durham, NC)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... training on new and existing programs, eg workplace harassment, performance management , management development training, etc.Assist with employee… more
- Aequor (Thousand Oaks, CA)
- … when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in ... plant to add value to the network: Manufacturing, Process Development , Supply Chain, Quality , and Facilities &...to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs… more
- AUROBINDO (Durham, NC)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history...The position is also required to work closely with Quality Control to make sure that the process flows… more
- Merck & Co. (Upper Gwynedd, PA)
- …understanding of related pharmaceutical operations (eg, manufacturing, formulation and process development , analytical, quality assurance , n ovel modality ... documentation to confirm acceptability and identification of potential risks.Lead the development , communication, lifecycle management and review of the CMC… more
- Merck & Co. (Rahway, NJ)
- … Process, Manufacturing, Manufacturing Environments, Mechanical Apptitude, Pharmaceutical Development , Pharmaceutical Manufacturing, Pharmaceutical Quality ... Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables gain of… more
- Merck & Co. (Durham, NC)
- …Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management , Deviation ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- AUROBINDO (Durham, NC)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing… more
- Merck & Co. (Rahway, NJ)
- … Management Process, Manufacturing, Mechanical Apptitude, Pharmaceutical Development , Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance ... Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables gain of… more
- AUROBINDO (Dayton, OH)
- …consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing… more
