- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site operations through data ... while leading, developing, and motivating a cross functional team of internal employees and external service providers.Successfully navigate challenges and influence… 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. (Millsboro, DE)
- …projects with a high level of technical difficulties and internal constraintsScheduling and planning for department requirementsCoordinate with department personnel ... to meet internal customer needs and requirementsCoordinate resources between areas of...equivalent and five (5) years direct experience Bachelor's degree preferred Required Experience and Skills: At least five years… more
- Novo Nordisk Inc. (Tyler, TX)
- …NNI-approved solutions Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and ... customers and patients' needs, and keeping commitments Develops and sustains internal relationships by collaborating across functions (eg Market access, Educators,… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Collaboration, Statistical Design of Experiments (DOE), Statistical Process Control (SPC), Technical Leadership, Technical Writing, Technology Transfer- Preferred ... substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in… more
- Merck & Co. (Rahway, NJ)
- …as mass spectrometers and other spectroscopic techniques.Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the ... characterization.Provide documentation/technical input during inspections and audits (Regulatory and Internal ) and have a working knowledge of data integrity and… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
- Merck & Co. (Rahway, NJ)
- …to 30% of the time.-Driving is also required for certain domestic audits. Preferred Experience and Skills:A professional audit and/or control , security ... 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
- Novo Nordisk Inc. (Walnut Creek, CA)
- …for them Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and addressing ... and where they currently position NNI products and devices Exercises prudent control over samples and other company property in accordance with company policies… more
- Merck & Co. (Durham, NC)
- …implementation of any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance.- ... projects.-Provide mentorship and coaching to ensure team success.SME support during routine internal and external GMP and Financial audits, input to QSAT actions, to… more
- Merck & Co. (Rahway, NJ)
- …participation.Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent ... under tight timelines in a rapidly changing environment.Experience leading internal and external cross-functional, matrixed teams.Demonstrated scientific leadership with… more
- Twist BioScience (South San Francisco, CA)
- …with Google Suite and/or MS Office Products required. Experience with Master Control , Atlassian Confluence and/or JIRA preferred . Strong written and oral ... SDS generation. Manage the review, approval, and distribution of SDS to internal and external stakeholders. Carries out duties in compliance with established… more
- Aequor (Collegeville, PA)
- …invoice terms, discounts, taxes, eligibility for contract pricing, and may control access to specified products. POSITION RESPONSIBILITIES: Create and maintain ... Requires Perform due diligence research including a comprehensive search of internal and external databases to determine and verify account's primary business… more
