Pharmaceutical Packaging Technician II
4 weeks ago
Catalent Inc is seeking a skilled Pharmaceutical Packaging Technician II to support clinical trial projects through the packaging of clinical trial supplies. The ideal candidate will ensure all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).
Key Responsibilities:
* Ensure site's safety, quality and compliance metrics are met or surpassed while meeting corporate and site standards and policies
* Execute clinical and commercial batch records in both primary and secondary packaging areas
* Alert management of any potential deviations or infractions in a timely manner
* Maintain and stay current on all necessary training required to support both primary and secondary packaging operations in Compliance Wire and all other GMP and work-related classroom training
* Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs
* Prepare, complete and correct documentation following GDP and in compliance with SOPs and cGMP
* Inspect drug product, components and clinical labels for defects, blemishes or missing text prior to and during production. Label application to consistently follow all visual/written procedures
* Understands GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites) and ensures compliance
* Able to mix and handle cleaning detergents for cleaning processing areas and packaging equipment. Clean associated packaging equipment and packaging room(s) in compliance with SOPs
Requirements:
* High School Diploma
* Relevant experience in Clinical trial packaging or related manufacturing/operations experience highly preferred
* Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required
* Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds
* Required to be able to work with respirator (P100, PAPR)
* Occasional requirement to work in cold environment of 2-8°C and/or -20°C to fill orders (walk-in refrigerator/freezer)
About Catalent Inc:
Catalent Inc is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. We offer a diverse, inclusive culture, positive working environment focusing on continually improving processes to remain innovative, and potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
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