- Insmed Incorporated (NJ)
- …cross-functional teams (Regulatory Affairs, CMC, Clinical, Quality) to facilitate document authoring, review , approval, and publishing workflows.Conduct ... requirements. The role has a strong focus on eCTD publishing and document management within Veeva Submissions Vault, ensuring accuracy, compliance, and timely… more
- Merck & Co. (Durham, NC)
- …with media, biological drug substance and drug product. Strong Background in cGMP document review and approval. Strong background in cGMP compliance standards ... and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site review , critical alarm management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be ... within the siteReview and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will also provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. ... process, operational, and quality improvements for manufacturing.Assist in the review and development of process-related protocols and documentation.Provide technical… more
- Larimar Therapeutics (Philadelphia, PA)
- …submissions or responses; coordinates document authoring (new or update), document review , and finalization of high-quality, style-guide compliant CMC ... support in-house regulatory submissions Experience with preparation (authoring and review ) of high-quality regulatory documents for global Health Authority… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Document Control Specialist as part of the Quality team based in Raritan, NJ.Role ... OverviewThe QA Document Control Specialist role is an exempt level position...with workflow handling and electronic system usage.Manage the periodic review process for procedures.Issuance of batch related documentation in… more
- Cipla (Fall River, MA)
- Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work Location : Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM ... QA QMS Lead Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible for managing controlled… more
- Aptyx (Charlotte, NC)
- …Support customer complaints Lead design changes to existing product lines as necessary Review document changes in manufacturing for impact on design intent ... to support quality system for design functions (project plans, concept document , FMEA, design input, test results, drawings, etc.) Complete activities as… more
- Twist BioScience (South San Francisco, CA)
- …quantitated high-throughput and attention to detail.Required to proofread, prepare, create, review , edit, and update Quality and Technical Documents including, but ... Synthetic Biology Manufacturing, and Gene Manufacturing highly desirableExperience with document management systems required.Experience with Learning Management Systems.Experience with… more
- Christus Health (Beaumont, TX)
- …RN will provide support and expertise through comprehensive assessment and review of inpatient medical records. The clinical documentation RN will facilitate ... finalize diagnosis Consistently meets established productivity targets for record review Designs and implements in collaboration with physician leadership specific… more
- JABIL CIRCUIT, INC (Angelus Oaks, CA)
- …training sessions for all applicable functions. . Develop appropriate systems for document storage, access and review pertaining to global customer accounts. ... maintenance of all documentation files; develop appropriate systems for document storage and access. . Review all...systems for document storage and access. . Review all supplier or customer discrepancies. Coordinate and track… more
- Merck & Co. (Rahway, NJ)
- …portfolio of work, holding the team accountable to deliver on priorities. Document preparation, maintenance, and review of documentation including specifications, ... testing protocols, testing reports, technical memos and supplier assessmentsRemain informed of current Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational execution ... of the company's Global We're looking for an Associate Director, Medical Review Committee Operations, on the Medical Review team to help us expand what's… more
- Merck & Co. (Rahway, NJ)
- …the end-to-end regulatory submission process. The main focus will be on document production processes, including content authoring, review and finalization, and ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… more
- Baylor Scott & White Emergency Hospital (Plano, TX)
- …two years Perform all Quality Assessment activities assigned to this position and document these activities for periodic review by the Laboratory Supervisor ... and/or the Laboratory Director Other Job Functions: Perform duties as ER Technician as needed Maintain an adequate supply of all reagents and consumables to perform quality testing Perform all routine daily, weekly, monthly, and periodic maintenance and… more
- McKesson (Nashville, TN)
- …protocols on which the patients are enrolled, screen and treat. You will review the study design and inclusion/exclusion criteria with physician and patient. You ... will complete and document screening/eligibility and consent accurately and have all parties...consent accurately and have all parties fully execute the document including HIPAA Authorization. You will complete the inclusion/exclusion… more
- McKesson (Dallas, TX)
- …which the patients are enrolled, screen, treat, and follow patients You will review the study design and inclusion/exclusion criteria with physician and patient. You ... will complete and document screening/eligibility and consent accurately and have all parties...consent accurately and have all parties fully execute the document including HIPAA Authorization You will complete the inclusion/exclusion… more
- Insmed Incorporated (NJ)
- …clarity, accuracy, and consistency Lead document workflows throughout document lifecycles for regulatory documents, including creation, review , approval, ... Maintain submissions and correspondence and archive regulatory files using Veeva Vault Document Management System Who You Are:You have a Bachelor's degree along with… more
- The Computer Merchant, LTD. (Quincy, MA)
- …all assigned HSN program\project activities, track progress, and coordinate quality review of required artifacts. Coordinate efforts of technical teams and vendors, ... Quickly acquire needed business knowledge and contribute to strategy recommendations. Review , approve, and sign off on assigned completed project deliverables;… more
- Cipla (Fall River, MA)
- …SOP's. In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This ... to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of master batch records. Develops… more
Related Job Searches:
Closing Document Review Specialist,
Document,
Document Review Associate,
Document Review Attorney,
Document Review San Francisco,
Document Review Specialist,
Document Review Staff Attorney,
E-discovery Document Review,
Law Document Review,
Review