- Tris Pharma (Monmouth Junction, NJ)
- …and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation , compliance efforts, quality operations, etc. Responsibilities:Assures ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Aequor (Waltham, MA)
- …and Project. This role will be: Reviews executed batch records and related documentation , resolves compliance issues and dispositions lots of drug substance, ... Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. Ensure that all requirements, as stipulated… more
- Merck & Co. (Rahway, NJ)
- …continuity of clinical supply and support registration targets.Ensure high quality documentation from external partners consistent with a compliance mindset. ... Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position will be part of the Global Compliance & Risk Management organization and will report directly to the Head of ... CBER submissions are complete, qualify for CBER, and contain all required documentation prior to distribution to CBER Reviewers. Responsible for coordinating the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of materials prior to dissemination.Assists OEDC leadership with timely submission and compliance of all required DS documentation for quality control/assurance, ... acts as a "change agent" within DS to ensure compliance and alignment with DS highest standards. This position...solutions.Acts as a change agent within DS to ensure compliance and alignment with DS highest standards. Uses quality… more
- Merck & Co. (Rahway, NJ)
- …processing, delivery processing, billing, and revenue recognition; working with trade compliance processes such as classification, licensing, documentation , and ... Job DescriptionDUTIES:Design and configure global trade compliance processes in SAP Global Trade Services (GTS) & SAP Order to Cash (OtC) modules.Develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation .Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation .Establishes… more
- Aequor (Swiftwater, MN)
- …to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets. The position is based in ... Mission The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …all documentation associated with EFP Change Controls and ensure compliance to Good Manufacturing Practice (GMP), internal Good Documentation Practices ... facilities, or processes are thorough, accurate, and justified.Advise end-users on documentation mechanisms to ensure adequate compliance to GMP.Leads or… more
- Merck & Co. (Durham, NC)
- …facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be ... work. Provide the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols,… more
- Eisai, Inc (Nutley, NJ)
- …cross-functional teams to implement necessary security measures.8. Incident reporting and documentation : Collaborate with the Global Security & Compliance team ... Operations Head and will dotted line report into the Global Security & Compliance team (second line of defense). The primary objective of this position is… more
- BioAgilytix (Durham, NC)
- …and check data accuracy before import to avoid errors and ensure compliance with laboratory standards. Instrumentation Integrationo Serve as the technical lead for ... comply with GxP, Part 11, and other regulatory requirements. Regulatory Compliance and Validationo Ensure the LabVantage LIMS meets all applicable regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.Global Clinical Study Start-Up ... Documentation : Reviews all clinical study protocols to ensure consistency...Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the process redesign… more
- Aequor (Newbury Park, CA)
- …relevant education. This position is primarily administrative, focusing on documentation coordination under managerial oversight. Description: In this vital role ... execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements. To manage and execute… more
- Eisai, Inc (Nutley, NJ)
- …Management Lead is responsible for overseeing the entire portfolio of IT Compliance responsibilities from both the strategic and execution perspectives for Eisai. ... Reporting directly to the Executive Director, IT Security, Compliance , & Architecture, s/he is the Global IT department's trusted leader and manager who assesses and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... decisions.Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, including… more
- Merck & Co. (Durham, NC)
- …ramp up of facility. Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to ... support project and future operations. Identifies and addresses compliance , environmental, safety, and process deviations as appropriate while coordinating with… more
- Aequor (Bothell, WA)
- …Knowledge, Skills, and Abilities:Comprehensive knowledge of Data Integrity guidance, GxP compliance , Software Development Life Cycle, and Good Documentation ... support in our Digital Plant organization working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and… more
- Merck & Co. (Durham, NC)
- …uses this knowledge in own workUnderstands and applies regulatory/ compliance requirements relative to their roleInfluence, motivate, and energize individuals ... be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation activities and… more
- Eisai, Inc (Nutley, NJ)
- …eTMF assist with set-up requests and Assists with filing and archiving project documentation in the eTMF within the defined timelines Performs eTMF internal reviews, ... Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COL Provides general enrollment figures to… more
