The Lead Specialist, QA - Batch Disposition is responsible for Quality Assurance support in the GMP documentation of biologic products. Responsibilities include reviewing manufacturing documentation, ensuring compliance with regulatory standards, and participating in quality improvement initiatives. The role requires collaboration with cross-functional teams and involves overseeing batch record accuracy and completeness.

The Lead Specialist in QA Batch Disposition is responsible for reviewing GMP documentation related to master/working cell banks and drug products, ensuring compliance with regulatory standards. This role involves batch record review, supporting lot disposition, and participation in quality improvement initiatives while interacting with internal teams and contributing to project teams.

The Quality Control Analyst I conducts routine and non-routine chemical and physical tests of raw materials and drug products, ensuring compliance with specifications. Responsibilities include performing analytical testing, operating instruments like HPLC and GC, analyzing data for regulatory submissions, and participating in quality investigations.

The Project Manager will independently manage projects at Catalent, overseeing planning, monitoring, and reporting on project timelines. The role includes client communications, documentation, SOP reviews, inventory management, and supporting project managers in their absence.

The Project Manager at Catalent will oversee project delivery from start to finish, including planning, execution, and documentation of projects in clinical supply. Responsibilities include managing client relationships, KPI reporting, compliance with SOPs, and supporting the team in meeting project goals.

The Project Manager at Catalent will independently manage projects from initiation to completion, ensuring proper planning, execution, monitoring, and reporting. Responsibilities include attending client meetings, maintaining documentation, managing inventory, and supporting lead project managers. The role requires experience in project management, particularly in clinical supply or regulated industries.

The Analytical Analyst will perform testing of raw materials and finished products, maintain laboratory standards, train personnel, and ensure compliance with SOPs and GMPs. Responsible for coordinating laboratory activities and supporting the advancement of pharmaceutical products.

The Batch Record Reviewer II is responsible for reviewing GMP documentation related to pharmaceutical manufacturing, ensuring compliance with regulatory standards, and identifying opportunities for quality improvements. The role involves evaluating batch records, addressing quality issues, and compiling performance metrics.

The Associate Scientist, QC will manage contamination control and sterility assurance for aseptic production at Catalent, overseeing microbiological testing and laboratory maintenance while ensuring compliance with regulations. Responsibilities include testing utilities, maintaining laboratory readiness, reviewing micro results, and performing microbiological analyses.

The Associate Scientist in Product Development at Catalent involves conducting formulation development and analytical testing under supervision. The role requires preparation of reports and maintaining compliance with SOPs and GMP regulations. Training in scientific techniques is provided, along with opportunities for problem-solving and client interaction, ultimately supporting pharmaceutical development.

The Director, Supply Chain oversees all procurement, planning, inventory control, and customer service functions, managing logistics and purchasing activities, ensuring project management disciplines are followed for new product launches, and develops long-term strategies in collaboration with operations while managing team performance.

The Manager, QA OTF is responsible for overseeing the QA on the Floor program, ensuring compliance with manufacturing procedures, and providing real-time reviews of batch record documentation. They will manage daily QA operations, ensure staff training on cGMP, and drive continuous improvement initiatives while resolving QA investigations and CAPAs.

The Supervisor, QA OTF is responsible for overseeing the QA on the Floor program, ensuring compliance with manufacturing procedures and batch records, reviewing documentation, and addressing manufacturing issues in real time. This role requires an active presence on the shop floor and supervision of personnel while ensuring adherence to safety guidelines and training. The position also includes collaboration with operations for quality oversight.

The Project Coordinator oversees projects from initiation to completion, ensuring timelines are created and followed. Responsibilities include inventory tracking, assisting Project Management teams, client communication, meeting facilitation, and managing project documentation.

The Project Coordinator at Catalent will manage projects from initiation to completion by tracking inventory, assisting project management teams, ensuring effective client communication, and overseeing project documentation and action items.

The Project Coordinator will oversee project coordination from inception to completion, ensuring adherence to timelines and managing client communications. This role requires tracking project inventory, maintaining documentation, and supporting project management teams with a focus on delivering exceptional customer service.

The Specialist, Client QA provides dedicated support for Quality Assurance in client projects related to GMP manufacturing. Responsibilities include quality oversight, tracking quality metrics, assisting regulatory audits, and maintaining databases. The role requires collaboration with various departments to ensure compliance and successful project completion while managing documentation and deviations.

The Quality Specialist I conducts audits of quality processes in production and packaging, ensuring adherence to quality standards. This role involves thorough documentation of non-compliance, collaboration with production teams, and compliance with regulatory standards. The specialist will also engage in computer data entry and assist with training and special projects as required.

The Manager, QA Analytical oversees the QA Analytical Team, ensuring compliance with cGMP standards during the testing of biopharmaceuticals. Responsibilities include managing daily QA operations, training staff, facilitating communication with various departments, reviewing analytical methods and documentation, and enhancing quality results.

The Regional Director leads the sales team focusing on achieving revenue and sales goals for oral solid dose manufacturing and softgel technologies. Responsibilities include defining sales strategies, engaging with customers, and fostering long-term relationships. The role requires collaboration with both internal teams and client management.