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Quality Assurance Document Control - Philadelphia Pennsylvania
Company: Disability Solutions Location: Philadelphia, Pennsylvania
Posted On: 04/24/2024
Job DescriptionQuality Assurance Document ControlPosition Summary:Catalent Pharma Solutions is Philadelphia, PA is hiring for a Quality Assurance Document Control.-- The Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished product.-- The Quality Assurance Document Control individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release.-- The Quality Assurance Document Control manages the communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.--This is a full-time role position: Monday - Friday, 7:30am-4:00pm.Catalent 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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging.-- Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.-- Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID--- safe storage labels for your studies. Single panel and Peel-ID--- safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role - Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
- Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
- Primary liaison with client for batch release.
- Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.-- Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
- Ensure timely release of batch for protocol initiation date.
- Release batch within scheduling database.
- Communicates SQDC countermeasures and safety issues to Quality Management.
- Ensures QADC metrics are met or acts to correct.The Candidate
- BA/BS Degree OR Minimum of a High School Diploma with relevant industry experience.
- Prior GMP experience strongly preferred.
- Experience with inspections or Batch Record Review a plus.
- Good organizational/time management skills and ability to multi-task.
- Challenges status quo and initiates improvements.
- Good communication and math skills.
- Advanced computer skills - including a high level of proficiency in Microsoft Office including Excel, Work, Outlook, IE, SAP/JDEWhy you should join Catalent:
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