- Novo Nordisk Inc. (Durham, NC)
- …Bachelor's degree in life sciences or related field of study from an accredited university required With P&O review/agreement, equivalent combination of education and ... About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manage the team responsible for oversight of warehouse activities that include release of incoming Apheresis, Raw material, Spot check, pack out of final ... of QA practices to ensure accurate documentation of all review and release activities for drug products, including manual and electronic practices.Establish and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Analytical Chemist I will provide analytical testing to support ongoing product release , raw material release and stability studies as needed, generate, ... and review technical documents that support raw material and product release and stability, will be responsible for managing activities with good time management to… more
- Merck & Co. (Rahway, NJ)
- …to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release , and maintenance in support of our company's clinical supply programs. ... and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions.--… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Assay Data, Gown/Pipette Qualifications, Generated Reports and CoA's as applicable.Support the release of documentation pertaining to the release of patient ... that include all Quality Control Departments including QC Critical Reagents, QC Release , QC IPL, and QC Lab Services.RequirementsA minimum of a Bachelor's Degree… more
- Novo Nordisk Inc. (Durham, NC)
- …within assigned area of accountability. Responsible for ensuring testing of in-process, release , and stability samples are performed in accordance with cGMP, NNPILP ... to ensure data integrity and timely reporting for batch release as needed Facilitate problem solving, investigations, and process...Expert in the area of chemical analysis of in-process, release , and stability testing required We commit to an… more
- Insmed Incorporated (San Diego, CA)
- …activitiesPerform ongoing review of batch records as part of product release , oversight of deviations and CAPAs, and ensuring appropriate communication of ... and in providing or reviewing responses to findings from such inspections.Responsible for release or rejection of GMP materials and coordinate with QA staff to… more
- Twist BioScience (South San Francisco, CA)
- …leverage new software features.Support Software UsersWork with teams to define post- release software issuesWork with internal software teams to resolve software ... record of successful software releases including validation, user training, post- release issue definition and resolution.Understanding of database design and SQL… more
- Merck & Co. (Durham, NC)
- …resources, as necessary to support Manufacturing.Additional Responsibilities GeneralConducts release testing in support of finished product, including sterility ... ExpertiseCompletes assignments in alignment with department objectivesConducting In-Process and Release testingConducting Environmental Monitoring of processes and on a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sound strategical approaches to complex investigations and associated CAPAsCollaborate with Batch Release team and communicate any roadblocks which may delay batch ... release and identify solutions to mitigate riskManages cross-functional projects with many stakeholdersLead continuous improvement associated with laboratory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality issues to managementEscalate to management about issues delaying product release or investigation closureMonitor timely completion of batch release ... related impact assessmentsSupport compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPsCollaborate with site personnel to provide guidance and determine resolution for manufacturing issuesReview critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to optimize system performance and functionality. - Data Quality, Testing and Release ManagementEstablish and enforce robust data governance standards to ensure the ... and troubleshoot any identified system issues.Lead and participate in regular system release management and testing of the HRIS platform(s). Perform robust reviews… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to support business needs such as raw material, in-process, method transfer, release , and/or stability testing.Reviews and approves documents to release of ... components, raw materials and drug products.Provides troubleshooting support as neededPerformance and documentation of laboratory investigationsInternal auditing and handling of external audits by customers and FDA during departmental reviewPurchase equipment… more
- Merck & Co. (Rahway, NJ)
- …to design, execute and/or direct the development and qualification of release , characterization, and stability assays for testing of clinical trial material ... and in support of product and process development.A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay… more
- Merck & Co. (Durham, NC)
- …cost . - Responsible for Shift(s) supply performance metrics ( Schedule Adherence , Release on Time, Customer service performance , Product Lead Time, etc.) . - - ... Continuous Improvement - Accountable for developing aP roduction System (MP S ) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s) . Develop strategic initiatives related to the manufacturing process, equipment… more
- Merck & Co. (Durham, NC)
- …Quality Assurance.Required Experience and Skills:Strong Batch Record Review and Release experience in electronic systemsPrevious investigation and CAPA experience, ... Batch Record Review, Validation IQ, OQ, PQ, Change Control.Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.Is expected to possess a high degree of problem-solving ability.Must have demonstrated ability to independently… more
- Twist BioScience (South San Francisco, CA)
- …and preventative actions in continuous improvement efforts.Participate in release upgrades or new functionality/enhancement assessments and make ... recommendations.Ensuring 100% compliance with all regulatory and security requirements associated with SOX and other audits for all in-scope applications.Interacted with business partners and IT teams, including internal and external consultants, to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and conduct capability analysis regularly Align with stakeholders, implementers and Agile Release Train (ART) to ensure product viability Create success criteria for ... testing and product acceptance Be an evangelist and subject matter expert to the suite of products and solutions Understand several perspectives in the development process including technology dependencies, needs of the user, capabilities of developers, vision… more
- Aequor (Bothell, WA)
- …of the QC Associate position is to perform GMP testing to support product release and in-process testing within the QC Microbiology Department. This role will also ... provide technical support and troubleshooting for analytical or microbiological tests.Duties & Responsibilities:Experience with microbiology techniques such as environmental monitoring, microbial identification, water/gas sampling, and… more
- Aequor (Pearl River, LA)
- …Growth Promotion, BCA, TOC and Conductivity Testing Plate reading, sample release , paperwork, data review and data input into computerized systems. Additional ... duties will include: Review and creation of standard operating procedures. Data entry/ data analysis of all sample results (EM and Utilities Testing, In-Process and Batch-Related). Receipt and storage of all samples coming into the QC Micro Lab. Assist… more
Related Job Searches:
Build Release Engineer,
Devops Build Release Engineer,
Information Review Release Analyst,
Release Engineer,
Release Information Specialist,
Release Manager,
Release Manager Engineer,
Release Project Manager,
Release Train Engineer,
Senior Release Manager