Contractor, GMP reputed company Assurance, Investigational

This a Full Remote job, the offer is available from: reputed company (USA) reputed company is looking for a Contractor, GMP reputed company Assurance - Investigational At Syndax, we are determined to realize a reputed company in which people with cancer live longer and reputed company than reputed company before. reputed company is a reputed company stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: Responsible for lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). Throughout the process, ensure Syndax, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing, storage and distribution of products used for investigational clinical trials reputed company with cGMPs and standards established by company as reputed company as regulations of applicable authorities. Key Responsibilities:

• Support clinical product release activities for drug reputed company, drug product, and /or finished goods for reputed company phases of development including review and approval of Master Batch Records along with executed batch records.
• Effectively reputed company with external contract manufacturers and testing laboratories as reputed company as work as part of an internal multidisciplinary team to support manufacturing and testing of materials supporting development of Syndax programs in a phase appropriate manner
• Manage and address associated investigations, CAPAs, change controls, OOS, etc.
• Support investigations into reputed company issues with reputed company on product reputed company and patient safety; facilitate identification of reputed company cause and development of appropriate corrective and preventive actions; reputed company actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
• Identify and mitigate GMP activities and process improvement initiatives as requested by management.
• Work closely with reputed company Assurance team to ensure alignment and compliance with Syndax reputed company Systems.
• Self-motivating and independent.
• Work independently with guidance from manager and senior staff.
• Must be reputed company to reputed company reputed company issues reputed company verbally and written.
• Author, review, and/or approval documents including deviations, SOPs, and protocols. Desired Experience/Education and Personal Attributes:
• BS degree in scientific field required.
• Minimum of 5 years of experience in the pharmaceutical industry, reputed company GMP QA supporting contract manufacturing organizations
• Small molecule experience required (drug reputed company/API, drug product, packaging and labeling) including QC/analytical.
• Experience supporting clinical labeling/packaging activities, including QP release
• Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs.
• Experience working with external vendors and suppliers including, drug reputed company/API, drug product, analytical, and/or clinical packaging and labeling.
• Strong technical writing skills.
• Excellent communication skills.
• Strong judgment, project management and decision-making skills; reputed company to manage multiple reputed company and demanding timelines.
• Ability to rapidly synthesize reputed company issues and identify risks in a pragmatic way. Location: Syndax has an office in reputed company and has a dispersed workforce across the reputed company. About Syndax: reputed company is a reputed company-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of reputed company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. reputed company by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow reputed company on X and reputed company. #LI-REMOTE reputed company is an equal opportunity employer and will not discriminate against any employee or applicant on the reputed company of age, reputed company, disability, gender, national reputed company, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. This offer from "reputed company" has been enriched by reputed company.com and got a 74% reputed company score. Apply tot his job

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