- AUROBINDO (Durham, NC)
- …secure resources needed to drive completion.Must be able to lead/mentor others on documentation and documentation review .Must possess excellent oral and ... operating procedures, and cGMPs. Previous GMP laboratory experience and technical reviewer experience are required. Review experience within an electronic… more
- Revel IT (Tucson, AZ)
- …raw material and finished goods testing. The individual will be responsible for review , generation and sign-off of quality documentation . The candidate will be ... in-process and finished goods test results. Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …labels, forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance ... Operations team based in Raritan, NJ. Role OverviewThe Batch Record and Documentation Coordinator will work in a detail-oriented compliant manner coordinating the… more
- Merck & Co. (North Wales, PA)
- …improvements or training may be requiredParticipate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for ... Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review , Employee Training Programs, FDA Regulations, IT… more
- Merck & Co. (Rahway, NJ)
- …for and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... in equipment design and testing as well as preparation, review , and completion of GMP documentation . Support...as preparation, review , and completion of GMP documentation . Support compliance with Industrial Hygiene (IH) program by… more
- CHRISTUS Health (Palestine, TX)
- …cleaning/decontaminating the aircraft/base, inventory of supplies and equipment, CQI/peer review , patient follow-ups, and obtaining appropriate rest as needed for ... certification within 6 months year of hire E TPATC or ATLS (Audited) [or documentation of in-house equivalency course] E required within one year of hire. Incident… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation , in accordance with Good Documentation ... to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support Floor Spot-check,… more
- AUROBINDO (Dayton, OH)
- …not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation ) when performing tassigned activities. Review and prepare technical ... with supervisory direction.Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.Prepare and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on the type of changes made and managing printing of documentation and labels required for Technical Protocol runs.Key Responsibilities Will be accountable ... incorporate all latest regulatory and quality requirements.Track relevant KPIsEnsure periodic review of all GMP documents are completed on time.Support … more
- JobElephant (Las Vegas, NV)
- …of system-wide contracts for the Chancellor's signature; which includes receipt, review for routing requirements, and circulation for signatures; preparing for ... review by the Chief General Counsel and/or staff attorneys...of legal documents, court pleadings or other administrative proceeding documentation . Legal research using Westlaw system. Draft correspondence, schedule… more
- Aequor (Davie, FL)
- …studies in coordination with planning, manufacturing, quality, LTS and PM groups. Review and analysis of the analytical and statistical data to support the ... timely completion of the action items (if any) Maintenance of appropriate documentation of protocols, reports, and laboratory notebooks as required by Standard… more
- BioAgilytix (Durham, NC)
- …and execute experiments, troubleshoot assays, analyze data, and prepare study documentation in alignment with GLP requirements. This is an excellent opportunity ... prompt identification and notification of deviations and preparation of associated documentation .Set up and manage studies in LIMS; maintain accurate laboratory… more
- buyer (New York, NY)
- …letters in accordance with mandated time constraints as applicable and conducts review prior to mailing.Manage, analyzes, and coordinates the daily activities of the ... reviews of recorded calls via the queue and care management documentation , care planning, follow up and interventions.Works collaboratively with MLTC management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.Create, review and approve relevant QC documents, ... SOP's and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process… more
- Merck & Co. (Rahway, NJ)
- …reporting and risk management activities, help maintain PV databases and documentation , and provide general administrative support for PV operations. This role ... and compliance in a regulated environment.- - Key responsibilities: - Enter, review , approve, and submit individual case safety reports for assigned products-… 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 ship.Assists 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
- Eisai, Inc (Nutley, NJ)
- …use of funds, and economic trends. Additionally, this individual will review cash requirements, plans and prepare short-term investments/borrowings to optimize daily ... opening, modification and closing process and ensure all bank account documentation (ie Corporate Resolutions, Authorized Corporate Signers & Bank Signers) is… more
- Genscript USA Inc. (Piscataway, NJ)
- …lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals ... commissioning of MEP systems, ensuring performance verification and turnover documentation are complete. Support construction scheduling, cost control, and quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities.Execute, own, assess and participate in the creation, revision and review of change controls, SOPs, and other documentation .RequirementsBachelor's ... technical writing skills to author manufacturing SOP's or technical documentation as needed.Experience with process modelling and optimization.Experience with new… more
- Aequor (Thousand Oaks, CA)
- …sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance ... Excellent communication skills Time management Proficient computer skills (ie documentation systems, databases and spreadsheets). Bachelor's degree OR Associate's… more
