- Aequor (Thousand Oaks, CA)
- …accuracy. Job Summary This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to directly support both manufacturing and ... Quality Control operations. Under minimal supervision analyze environmental monitoring samples,...investigation of out-of-specification and/ or non-conforming test results. Supports internal and external inspections and audits as needed (lab… more
- Twist BioScience (South San Francisco, CA)
- … control environmentSupport the annual audit and tax complianceDevelop scalable internal controls within the accounting function and intersections across the ... organizationFoster a control environment that rewards integrity and objectivity while ensuring...that rewards integrity and objectivity while ensuring all related internal controls are consistently adhered to and… more
- Merck & Co. (Rahway, NJ)
- …technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Merck & Co. (Rahway, NJ)
- …assessments across all our company's divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area ... knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex business scenarios in accordance with… more
- Repligen (Waltham, MA)
- …and quarterly close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ledger accounting, ... including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit requests from internal… more
- Tris Pharma (Monmouth Junction, NJ)
- …continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross functionally with internal ... Research and Development (R&D), Finance, etc.) to support purchasing controls /budget and a comprehensive procurement strategy aligned with organization's overall… more
- Aequor (Tampa, FL)
- …and company policies. Withholding Tax and Tax Treaty Compliance Execute and oversee controls to verify the correct application of tax treaties and withholding tax on ... provisions, and manage tax balance tracking accurately. Supervise monthly e-invoicing controls to ensure compliance and accuracy. Forecasting and Cash Flow Support… more
- Repligen (Waltham, MA)
- …and supporting strong analytical approach with teams across the organization. Internal Controls & Compliance:Design, implement, and maintain effective ... internal controls over financial reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(PV) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from the affiliate perspective ... Time' mindset to effectively perform quality assessments and deliver quality control on identified areas of focus within external pharmacovigilance (PV) partners… more
- Twist BioScience (South San Francisco, CA)
- …cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, ... of manufacturing data, deviation management, and electronic signatures.Vendor & Internal Resource Management: Manage relationships with any external software… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the ... organization. Internal relationships include close interactions with marketing, sales, extended...Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual curiosity,… more
- Eisai, Inc (Exton, PA)
- …with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Merck & Co. (Rahway, NJ)
- …leadership will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and ... all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or… more
- Eisai, Inc (Raleigh, NC)
- …assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to resolve quality-related issues.Key ... disposition.Maintain associated documentation and records electronically in accordance with internal standards.Support approval and issuance of Master Batch Records… more
- Repligen (Waltham, MA)
- …ISO 9001 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls , and ... the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; serve as host for site… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required documentations and… more
- Formation Bio (New York, NY)
- …Zip, including ensuring coding accuracy, proper PO matching, and compliance with internal controls Administer Navan for travel and expense reporting, including ... employee reimbursements, system configurations, user onboarding/training, and coordination with internal stakeholders Perform monthly bank reconciliations and support other… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control , MSAT, and Engineering to support and improve the planning processes ... automation models using available data Ensure effective communication with both internal and external stakeholders Support internal /external Logistics teams to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support ... the delegate for the Head of Operations.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within… more
- Aequor (Tampa, FL)
- …completes CAPA in response to laboratory investigations. Manages change controls effectively. Manages/ supports microbiology projects from production or formulations ... of environment, equipment and facilities. Manages product testing based upon internal and customer specifications. Managing 3rd party laboratory testing and… more
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