- Aequor (Swiftwater, MN)
- Shift: 1st Work Schedule: 8AM - 4PM EST Mon-Fri Quality Control Technician II (Manufacturing/Quality) 1st Shift: QC Instrument Support (QCIS) Description This ... position will support the lifecycle management of instrumentation within the Quality Control department at the Swiftwater, PA location while strictly adhering to… more
- Aequor (Thousand Oaks, CA)
- …remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details: Under general ... NC/CAPA/CC) and process improvements projects to support Corporate Quality Control . Specific responsibilities include performing investigations to support corrective… more
- Merck & Co. (Durham, NC)
- …chromatography columns).Support Equipment (eg washers, autoclaves, tube welders/sealers). Automated Systems (eg Distributed Control System (DCS), Programmable ... be required to be fully vaccinated as a condition of employment.The Lead Maintenance Technician is a leader with strong interpersonal, communication, and… more
- Merck & Co. (Rahway, NJ)
- …Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing Controls and Device ... build QMS capabilities that touch every aspect of our business processes, systems , and data.The Associate Director will collaborate and interact with cross-function… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Merck & Co. (Durham, NC)
- …utility generation equipment, functional with PLC's, VFD's, and automation (BAS) and control systems in a Good Manufacturing Practices ( GMP)environment.Must be ... Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequired Skills:HVAC Control Systems , HVAC Engineering, HVAC Equipment, HVAC… more
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Merck & Co. (Durham, NC)
- …Project coordination leadership and implementation of troubleshooting activities and change control . Initiate and lead collaboration within the Operations, ... Alum production.- Responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance with SDLC,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as a conduit for sharing of best practices to/from other M2-US or NN teams Lead document control process across site Design & own process for implementation of ... processes. Ensures alignment of training processes to corporate & quality systems . Responsible for maintaining Standard Operational Procedures (SOPs) for the site.… more
- Merck & Co. (Durham, NC)
- …coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations, Quality ... Alum production.- Responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance with SDLC,… more
- Merck & Co. (Rahway, NJ)
- …Immunochemistry, Maintenance Supervision, Mammalian Cell Culture, Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing Systems , Regulatory ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory submissions Support… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Repligen (Waltham, MA)
- …teamResponsibilitiesGlobal Compliance Leadership:Develop, implement, and maintain an effective internal control framework that spans all global operations. Lead ... relationships with external auditors, regulatory agencies, and industry peers.Operational Excellence: Lead root cause analyses for identified control deficiencies… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA… more
- Merck & Co. (Rahway, NJ)
- …and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance, ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Durham, NC)
- …to Work Under Pressure, API Manufacturing, cGMP Regulations, Change Control Systems , Chemical Engineering, Chemical Process Development, Cross-Cultural ... is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate with their… more
- Formation Bio (NC)
- …for a builder who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and ... infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and transform unstructured and structured research, biomedical… more
- Merck & Co. (Rahway, NJ)
- …to ensure compliance and reduction in workplace Industrial Hygiene risks. Lead global continuous improvement initiatives to improve global Industrial Hygiene ... programs.-Building Industrial Hygiene capabilities by simplifying existing and creating new systems and tools that enables our customers to adapt Industrial Hygiene… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and timely assessments associated with change control activities Ensures change control activities for systems are completed in a manner in compliance ... may be available for elgibile candidates. Relationships Reports to: Lead Engineer, Validation (Supervisor) Essential Functions Primary responsibilities include… more
