- Aequor (Fort Worth, TX)
- …and assays. Perform visual inspections of finished products. Participate in internal assessments and audits as required. Identify and troubleshoot equipment ... regarding their use. Serve as a technical liaison between quality control and other departments, vendors, or contractors. Coordinate testing with contract… more
- Aequor (Fort Worth, TX)
- …samples and finished products for contamination or abnormalities. Participate in internal assessments and audits related to biological testing and biosafety ... Write or revise standard operating procedures for biological and microbiological quality control . Supply biological quality control data necessary for regulatory… more
- Repligen (Clifton Park, NY)
- …in science or relevant experience preferred.Experience in Quality Assurance (QA) or Quality Control (QC) is a plus.Strong attention to detail and ability to work in ... factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible… more
- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be ... audit, public accounting, or general accounting.Experience with audit methodology and internal controls .Excellent interpersonal skills, including the ability to… more
- Merck & Co. (Rahway, NJ)
- …and assessments across all our Company divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area ... and techniques to independently assess risk and evaluate the effectiveness of internal controls in business scenarios in accordance with timelines.Applies body… more
- Tris Pharma (Monmouth Junction, NJ)
- …Controller ensures Accounting policies and procedures align with US GAAP and internal control standards, while proactively identifying and resolving complex ... as needed; Assists in generation and advancement of assigned process improvements, internal controls and optimization of business processes impacting company and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for ensuring that all rebate controls meet all audit and internal control (Sarbox) requirements Physical Requirements 0-10% overnight travel required. Novo ... responsible for gross-to-net forecasting for the US business, ensuring external and internal customer alignment as necessary. The position is responsible for: Lead… more
- Vaco by Highspring (Boston, MA)
- …with professional standards for internal auditing Assess processes and internal controls are appropriately designed and operating effectively to mitigate ... financial, operational, regulatory and compliance risks Plan and execute testing of Internal Controls over Financial Reporting (SOX) Provide assurance over key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scope includes working on Quality related sub-teams such as change control sub-teams and investigational sub-teams. The material/ raw material scope includes ... validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material sub-teams to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure local process compliance. Acts in role of process SME for the Change Control process at USO. Support internal and external stakeholders with issue ... domain. Acts in role as process SME for the Content Control process across USO. Support internal and external stakeholders with issue resolutions in a timely… more
- Merck & Co. (Rahway, NJ)
- …regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design controls , device transfer, control strategies, device risk ... 4 years in managing external partners and suppliers.Proven expertise in design controls , risk analysis, control strategies, design verification testing, and… more
- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be ... audit, public accounting, or general accounting.Experience with audit methodology and internal controls .Excellent interpersonal skills, including the ability to… more
- Insmed Incorporated (NJ)
- …includes shaping policies, guiding training efforts, and building operational controls across project development, construction, commissioning, research and asset ... response plans and investigate accidents and environmental incidents.Conduct and manage internal and external EH&S audits and surveys, analyze results, and provide… more
- Insmed Incorporated (NJ)
- …of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews.What You'll Do: Responsibilities ... multiple projects at the same time. Provide operational support like change controls , release management, and reviews of validated systems. Author CSV Documents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …general investigations, security related compliance issues, physical and logical access control and profile management of all employees, contractors and visitors. ... group, contract security force, security vendors, as well as various internal stakeholders. The manager develops networks internally and externally to influence… more
- Cipla (Central Islip, NY)
- …analysis and corrective actions. Work closely with QA, AQA, operations, quality control , and other departments to gather information and implement solutions. Ensure ... product quality. Conduct risk assessments for proposed changes and implement necessary controls . Ensure all changes are properly documented and approved according to… more
- Insmed Incorporated (NJ)
- …compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The position is critical in ... programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial… 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
- Formation Bio (New York, NY)
- …implications of business initiatives Assists the Director of Accounting in enhancing internal controls and reporting precision Participates in accounting system ... and M&A transactions Consolidation, Investments, and Entity Structuring Analyzes control , ownership, and consolidation implications for new and existing… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, ... ManagementAuthor and revise SOPs related to investigations and quality control .Ensure documentation is complete, accurate, and compliant with regulatory standards5.… more
