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The Process Scientist I supports transfer and process development activities by collaborating with teams on GMP batch manufacture and optimization, maintaining inventory, and assisting with documentation for regulatory submissions. Responsibilities include planning development batches, writing SOPs, and maintaining accurate documentation in compliance with GMP guidelines.
The Zone Operations Manager oversees the manufacturing team to ensure quality and timely production of pharmaceutical products. They manage technician allocation, ensure compliance with cGMP standards, troubleshoot operational issues, and coordinate with other departments. The role requires effective leadership, performance evaluation, and training execution.
The Quality Assurance Specialist I will oversee the quarantine process, audit production and packaging, review incoming materials, and ensure compliance with quality standards and regulatory requirements, including FDA and cGMP. Responsibilities also include documenting non-compliance issues and participating in training.
The Quality Assurance Associate ensures quality compliance in pharmaceutical manufacturing. Responsibilities include performing audits, quality checks, training staff on documentation and cGMP requirements, investigating manufacturing issues, and preparing compliance reports. This role acts as a QA representative during shifts, ensures final product release meets standards, and verifies equipment during product changeovers.
The Sr. QC Scientist - LIMS Administration at Catalent Pharma Solutions is responsible for managing accounts and implementing the LabVantage® LIMS at the BWI Harmans site. This role involves providing end-user support, ensuring system compliance, and participating in design modifications.
The Master Scheduler oversees the development and maintenance of the Master Schedule and short-term production schedules for Catalent's Commercial and Development products. They partner with various teams to translate requirements into schedule, monitor daily operations, and facilitate production capacity reviews, ensuring alignment across departments and timely delivery of products.
The Senior Specialist, QA OTF at Catalent is responsible for providing Quality Assurance support for GMP Manufacturing of biological products. This role involves on-the-floor oversight of manufacturing operations, reviewing documentation for compliance, and ensuring systems and procedures are in line with regulatory standards and quality improvements.
The Manager, Quality Systems Audit at Catalent is responsible for managing and overseeing core quality systems including investigation/deviation management, CAPA tracking, change control, risk management, and compiling quality metrics for Senior Management review.
The Quality Specialist I at Catalent in Greendale, Indiana is responsible for auditing products and processes to ensure adherence to quality standards. This role involves conducting quality audits, reporting deviations, documenting non-compliance areas, and collaborating with the Quality Assurance team. The candidate must have a high school diploma (BS in Food Science preferred) and knowledge of GMP and Quality systems.
The Manager, Supplier Quality is responsible for managing and overseeing core quality systems related to Supplier Quality Management, including supplier qualification, quality agreements, audits, complaints, CAPA tracking, and risk management. This role also involves compiling and reporting key Supplier Quality metrics for Senior Leadership review and managing the Supplier Quality team at Catalent Gene Therapy sites.
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