Job Description. Performs routine production functions including filling, utility operations, packing, packaging, assembling, labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization). Effectively works in a team setting, supporting team goals and objectives. Makes eff...
Job description. Collects environmental and utility samples for microbiological and chemical testing. Performs microbiological testing on water and swabs. Responsibilities. Implements, maintains, and makes changes to create global solutions for a safe work environment and good manufacturing practices in accordance with procedural requirements. Maintains training certifications as needed for assigned job tasks and takes responsibility to add new t...
Job description. Collects environmental and utility samples for microbiological and chemical testing. Performs microbiological testing on water and swabs. Responsibilities. Implements, maintains, and makes changes to create global solutions for a safe work environment and good manufacturing practices in accordance with procedural requirements. Maintains training certifications as needed for assigned job tasks and takes responsibility to add new t...
Responsibilities. Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process. You'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality. In addit...
Responsibilities. . The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. This is a mea...
Responsibilities. . The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. This is a mea...
Job Description. Implement, control and coordinate changes in documentation. Facilitates the updating and routing of controlled documents, including, but not limited to, Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS. Review documents, review document change requests and route document change requests to process document creation, maintenance, and implementation in eDMS. Control/distribution of controlle...
Job Description. The Manager, Quality Systems is responsible for providing end-to-end quality assurance oversight across designated manufacturing operations, which may include pharmaceutical products, medical devices, cosmetics, biologics, and combination products. This role ensures that all quality-related activities—from raw material receipt through final product release—are conducted in alignment with corporate quality policies, applicable reg...
Job Description. The Manager, Quality Systems is responsible for providing end-to-end quality assurance oversight across designated manufacturing operations, which may include pharmaceutical products, medical devices, cosmetics, biologics, and combination products. This role ensures that all quality-related activities—from raw material receipt through final product release—are conducted in alignment with corporate quality policies, applicable reg...
Roles & Responsibilities. Responsible for managing and overseeing the daily operations and projects at a client's location, acting as the primary link between the client, project team. Experience in R&D New Product Development & Design Change Management. Experience in Product Life Cycle management, developing, Risk Management activities, Design Verification & Validation activities.
Roles & Responsibilities. Documentation Management. Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines. Review production schedules with various departments to ensure alignment and efficiency. Manage the lifecycle of production documents, including creation, review, approval, and archiving. Manage the printing, distribution, and tracking of ...
Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs. Key Responsibilities. Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in...
