- 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
- 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
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and documentation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This role ... (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… 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)
- …Practices (GMP), Interactive Voice Response (IVR), Interpersonal Relationships, Inventory Control System , Inventory Management, Key Performance Indicators (KPI), ... the primary GCS point of contact to stakeholders both internal and external to GCS and serve s as...and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for… 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 ... subordinates with direct/indirect referral: N/A Essential Functions Update data in planning systems such as SAP, OMP, and RTMSto ensure integrity Assist with… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System , Inventory Management, Management Process, Multiple ... contact representing the GCS Planning organization to customers both internal and external to GCS and serve s as...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Twist BioScience (South San Francisco, CA)
- …a hands-on position that will be responsible for maintaining the company's internal financial statements and monthly financial close process. The Sr Manager ... records and controlsConsolidation of the monthly financial statements and internal reportingOwnership of the monthly close calendar, while proactively collaborating… 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, ... and producing reports, as needed. (currently utilizing Paylocity as our HRIS system )Assist in talent acquisition and recruitment processes by creating and posting… more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …in health care settings and major academic and large community health systems . The Specialty Field Sales Representative also assists their target physicians with ... for them Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and addressing… more
- Merck & Co. (Rahway, NJ)
- …substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in ... that elevate our standards.Engage Across Functions: Actively interact with internal and external partners, representing your functional area on cross-functional… more
- Tris Pharma (Monmouth Junction, NJ)
- …including receiving, storage and distribution of materials and products; Implements inventory control systems to maintain optimal stock levels and minimize ... strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and… more
- Novo Nordisk Inc. (Traverse City, MI)
- …of territory customer groups and affiliations such as IPAs, Medical Groups, Health Systems , and Local Clinics and uses this to identify business opportunities and ... NNI-approved solutions Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and… more
- Merck & Co. (Rahway, NJ)
- …security certification such as Certified Professional Accountant (CPA), Certified Information Systems Auditor (CISA), Certified Internal Auditor (CIA), Certified ... 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 audited.Coaches… more
- Twist BioScience (South San Francisco, CA)
- …Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience ... SDS generation. Manage the review, approval, and distribution of SDS to internal and external stakeholders. Carries out duties in compliance with established… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... Sending Unit, will facilitate transfer of analytical procedures to a Receiving Unit ( internal or external QC). May act as a program lead on a PDT as required by the… more
- Twist BioScience (South San Francisco, CA)
- …skills, knowledge, experience, and abilities; the location of the role; internal equity; and alignment with market data.Key ResponsibilitiesPipeline Design & ... workflow needs and translate them into robust, user-friendly bioinformatics solutions. System Architecture & Production EngineeringLead architectural decisions for bioinformatics… more
- Twist BioScience (South San Francisco, CA)
- …driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems .Superior interpersonal skills and ability to ... concept to launch. Additionally, you will have an opportunity to help shape the team's systems and processes as we continue to scale with the growth of the company.… more
