- Legend Biotech USA, Inc. (Raritan, NJ)
- …as well as other microbiological assays.Utilize electronic systems (LIMS) for execution, documentation , review of testing.Perform tasks in a manner consistent ... in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …logbooks, and records. Utilization of electronic systems (LIMS) for execution and documentation . Create, review , and approve relevant QC documents, SOP's and ... multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based in...operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …documentation . This position will additionally serve as a final Quality Reviewer /Approver for internal documentation . The Documentation Control Supervisor ... only made available to necessary personnel.Serves as the final Quality Reviewer /Approver for internal company documentation [e.g., Standard Operating Procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lead and biostat to ensure availability of necessary dataCoordinate author review /approval & internal review approvalSubmit abstract/manuscripts with vendor ... supportFacilitate response to journal reviewer comments/requestsTrack publication tracking and announcements, in coordination with MI/ELeads the planning and… more
- Merck & Co. (Millsboro, DE)
- …training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC), ... maintenance of animal facilities. This position is responsible for providing data, documentation , and other information as needed for annual reports to Federal… more
- Careers Integrated Resources Inc (Atlanta, GA)
- …Knowledge of clinical data auditing or HHS risk adjustment is helpful . Perform review on clinical data and abstract documentation to support identified Dx codes ... Job Title: Risk Adjustment Clinical Reviewer Location: 100% Remote Duration: 2 Months (Possible...databases . Work Experience: Experience performing chart audits and review preferred. Coding experience is a plus. Experience using… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …periodic review process for procedures, as needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP documentation ... Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with… more
- Careers Integrated Resources Inc (Newark, CA)
- Job Title: QC Analyst II ( Reviewer ) Location: Newark, CA Duration: 04+ Months Pay range: $38/hr. on W2 Responsibilities: . Perform routine and non-routine release, ... stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP. . Perform Analytical assays such as HPLC (SEC, IEX,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strategy, comparability plans and data governance initiativesProvide critical input and review for validation master plans, PPQ and comparability protocols and ... reportsServe as reviewer /author of a variety CMC sections or regulatory submissions,...response teamDevelop and align a variety of process validation documentation templates ranging from control strategies to PVP and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to...new and updated Core Data Sheets, EU and US Documentation : As the project lead, Independently or through direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …procedures, training, and process controls to identify, track, and maintain documentation around privacy requirements and data breaches. Conducts and maintains data ... privacy implications of business initiatives, product development, and marketing campaigns. Review relevant data protection agreements in coordination with Legal and… more
- Aequor (Pearl River, LA)
- …software capabilities and functionality. Document programming standards and procedures. Track and review change control documentation . Assist with the editing of ... reports to management and project team on the status of documentation activities4. Ensure compliance with industry standards and regulationsNavigate Microsoft Word… more
- Aequor (Thousand Oaks, CA)
- …and portfolio skills. This position is a key member of the GxP Management Review Governance Team within the Quality Systems and Services organization. The QA Sr ... activities related to the execution of the L0 GxP Quality Management Review . Coordinating and Facilitating material creation and preparation sessions. Working with… more
- Aequor (Bothell, WA)
- …and Quality in accordance with company procedures and regulatory requirements. Author, review and/or approve applicable CSV documentation Assist Business Owners ... ERP systems (ie SAP or Oracle). Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ /… more
- Aequor (Parsippany, NJ)
- …Summary invoice, summary data file and Claim Level Invoice each quarter and review to ensure completeness of information received. Upload data into Medicaid systems ... ensure rebate eligibility and data consistency.20% Perform Claim Level Detail validation. Review suspect claim records and determines if record should be disputed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team adherence to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted by CROs and vendors.Provide ... input into study protocol profiles, final protocols and amendmentsLead document review & coordination for the protocol and amendments. Additional medical writing… more
- BioAgilytix (Durham, NC)
- …Qualification Reports Issue and review equipment Logbooks Assist with the review and approval of validation/qualification documentation for new and existing ... that facilitates organizational success and meets business needs.Essential Responsibilities Review and approve equipment work orders Maintain equipment in site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to shipAssists in ... master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation or qualification of global GxP and Non-GxP computer systems.Create and review various validation documentation such as Validation Plans, Protocols ... compliance, and global Quality expectations. Partner with global Quality departments to review global policies, inspections and audit CAPAs, and vendor audit … more
