- Merck & Co. (Durham, NC)
- …including technical reports and risk assessments Author or approve Change Control documentation for complex process, validation, analytical, equipment, ... control Authored complex deviation investigations Experience with validation documentation and execution Experience with SAP Experience with Manufacturing… more
- Repligen (Hopkinton, IA)
- …Quality Management System. This role is responsible for assisting the document control department in processing documentation requests. They will work closely ... subject matter experts, area managers and senior level Document Control and QA-personnel to properly convert documentation ...Document Control and QA-personnel to properly convert documentation into the final written form and ensure the… more
- Aequor (Thousand Oaks, CA)
- …required, as full training will be provided. Strong attention to detail, good documentation practices (GDocP), and comfort with lab notebooks and SI pages are ... is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory logbooks. Preferred… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer based) according to GMPs Demonstrate the philosophy of… more
- Aequor (Swiftwater, MN)
- …position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming ... pre and post-run setup and maintenance. Complete required paperwork and documentation as required. Troubleshoot sample discrepancies. Perform peer proofing on… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This position ... instruction on new tasks. Relationships Reports to: Supervisor of Quality Control Number of subordinates with direct/indirect referral: n/a Essential Functions… more
- Merck & Co. (Millsboro, DE)
- …Healthcare Innovation, Laboratory Maintenance, Mammalian Cell Culture, Manufacturing Documentation , Manufacturing Operations, Manufacturing Quality Control , ... record keeping including charts, log books, and all pertinent documentation .-Identifies and addresses compliance, environmental, safety, and process deviations as… more
- Erias Ventures, LLC (Annapolis Junction, MD)
- …government decision makers, organize and relay government responses. Maintain documentation (eg, Standard Operating Procedure (SOPs), official responses to actions, ... Confluence, Siteworks, Corporate Data Repositories and shared directories Perform quality control on incoming requests, monitor, and process requests to closure… more
- Repligen (Waltham, MA)
- …and external financial reporting, including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit ... close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ledger accounting, account… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development, validation, and ... at all levels in the organization FUNCTIONAL EXPERTISE: The Specialist, Quality Control will be responsible for activities that support cGMP and regulatory… more
- FH Paschen (Chicago, IL)
- …with company quality procedures. Process, file and maintain project quality control documentation . Strong understanding/working knowledge of company quality ... of project teams to ensure they are complying with company quality control plan requirements and project contract requirements; assist in the implementation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …derive insights Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ... ability to solve complex unstructured problems; see opportunities through Experience analyzing pharmaceutical data, specifically Xponent, Xponent PlanTrak, data is required. Experience with data visualization (ie Tableau) tools preferred Innate intellectual… more
- Merck & Co. (Omaha, NE)
- …export country shipping metrics. The successful candidate will ensure that all documentation for the department has been completed accurately and will look at ... handle any export concernsWork with the markets to insure they have all of the documentation necessary to clear customs - Work with the plants to ensure the due… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience required. Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual curiosity, ... demonstrated desire to take initiative, and ability to think creatively to solve complex problems Ability to effectively integrate and communicate insights to Senior Management teams, synthesize complex information, making it relevant, understandable and… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience with… 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, ... The Receiving Supervisor must ensure that all the appropriate documentation has been provided to APUSA and submit the...position is also required to work closely with Quality Control to make sure that the process flows smoothly… more
- Merck & Co. (Rahway, NJ)
- …such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements ... IT Business Partners including activities relating to Requirements Gathering, Documentation , Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee… 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)
- …Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply ... chain documentation to support critical CMC activities . - Responsible...Knowledge of order management, supply chain operations and document control - #MSJR #eligibleforERP GCSCareer25 #VETJOBS #GCSCareer Current Employees… more
- Twist BioScience (South San Francisco, CA)
- …is responsible for ensuring the efficient and compliant management of regulatory documentation , with a primary focus on Safety Data Sheets (SDS), product labeling, ... crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll… more
