- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionThe Sr. Manager, GMP Quality Assurance is responsible for ensuring that all GMP -regulated ... ICH) and internal SOPs, Policies and Work Instructions Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary: Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier qualification program, ... CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. Establish lessons learned from audits/inspections...lead and or co lead due- diligence assessments of GMP facilities and or CMOs as deemed necessary. Ensure… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Merck & Co. (Rahway, NJ)
- …both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, ... new technologies, trialing new automation strategies, and implementing them in the GMP areasSupport capital projects, work to design, install, and qualify new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, ... for procedures.Issuance of batch related documentation in support of GMP manufacturing.Reconcile GMP documentation following document lifecycle… more
- Merck & Co. (Durham, NC)
- …shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdownsCoordinates with Site Engineering and IPT ... completed in accordance with established safety, Good Manufacturing Practices ( GMP ), and calibration/maintenance procedures.Establish processes that ensure required Safety… more
- Cipla (Hauppauge, NY)
- …records, ensuring that all documentation complies with Good Manufacturing Practices ( GMP ), regulatory standards, and internal quality assurance procedures. This role ... to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines. Verify that all entries are...compliant for both internal and external audits (eg, FDA, GMP inspections). Assist audit teams by providing required batch… more
- Aequor (Thousand Oaks, CA)
- …in Biology, Chemistry, Biochemistry, or related field, OR a candidate with hands-on QC GMP experience who may not hold a degree. Highly trainable and eager to learn ... with basic computer skills and documentation systems. Familiarity with GMP principles is a plus, but not a strict...or a related scientific field Candidates with hands-on QC GMP laboratory experience, even if a degree is not… more
- Merck & Co. (Durham, NC)
- …higher.Required Experience and Skills: At least one (1) year GMP manufacturing/processing experience.Demonstrated written and verbal communications skills.Must be ... Literacy, Digital Literacy, Driving Continuous Improvement, Freeze Drying, Global Manufacturing, GMP Compliance, GMP Operations, Good Manufacturing Practices (… more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- ValSource, Inc. (Worcester, MA)
- …technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network ... support our clients’ Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these… more
- ValSource, Inc. (Durham, NC)
- …commissioning, qualification, validation (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected ... US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Proficiency with Microsoft office including Word, Excel, and PowerPoint.… more
- ValSource, Inc. (Rahway, NJ)
- …exciting projects with our clients in the pharmaceutical and biotech and related GMP manufacturing industries throughout each of our regions in the US. The ... and equipment qualification activities, and ensuring compliance with FDA, GMP , and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface… more
- Cipla (Hauppauge, NY)
- …and conducting quality inspections. The role also ensures adherence to GMP and GDP standards, handles non-conformance issues, supports supplier management, and ... findings. Ensure all warehouse operations comply with Good Manufacturing Practices ( GMP ) and regulatory requirements. Participate in internal audits and ensure… more
- Merck & Co. (Durham, NC)
- …and Skills:Familiarity of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsPhysical requirements ... Systems (CMMS), Documentations, Engineering Processes, Equipment Maintenance, Facility Maintenance, GMP Compliance, GMP Operations, HVAC Systems, Lease… more
- Merck & Co. (Durham, NC)
- …automation documents, preventive maintenance, and SOPs toensure compliance with GMP and safety.Develops and supports corrective actions associated with automation ... skills and a proactive approach to problem-solvingPrevious experience in a GMP manufacturing related roleStrong written and verbal communication skills in… more
- Merck & Co. (Durham, NC)
- …to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns Coordinates with Site Engineering and ... completed in accordance with established safety, Good Manufacturing Practices ( GMP ), and calibration/maintenance procedures. Establish processes that ensure required… more
- Cipla (Fall River, MA)
- …to avoid time loss during any machine breakdown Prepare, review and update GMP documents to meet regulatory compliance and quality of product Prepare the facility ... CAPA in the block Ensure online documentation for any non-conformance to meet GMP by performing surprise checks Prepare and review the qualification, validation and… more
- Lundbeck (Bothell, WA)
- …design, optimize, and scale purification processes for biologics. Support production of non- GMP materials as needed, including production of tox study material in ... requirements. Support Process Sciences in technology transfer activities to GMP manufacturing facilities, ensuring compliance with regulatory standards. Required… more
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