Senior Specialist, Clinical Trial Supply QA (19-00646) – PA – Exton

The Senior Specialist CTS QA works with global supply chain teams (US and UK) and CMO (contract manufacturing organizations) on a daily basis to review and approve master batch records, production batch records, change controls, labeling specifications, SOP, and other GMP documentation to release clinical trial material (CTM) for release. In addition, the individual will act as person-in-plant at CMO during primary production (eg, bottling or blistering) and secondary packaging (kitting) and labeling operations.

Essential Functions
1. Independent decision maker for assessing suitability of CTM for human clinical trials
2. Evaluate process set-up and operation for design to reduce likelihood of error and communicate and influence CMO in process set-up and operation
3. Approve pre-production records (eg, specifications, master production records, change controls)
4. Approve prost-production records (eg, production batch records, deviations, investigations, and change controls)
5. Disposition CTM in accordance with regulatory dossier filing
6. Evaluate existing Client processes for effectiveness and develop, revise, and maintain SOP to support CMO operations for primary and secondary packaging and labeling
7. Ensure CMO compliance to GMP and Client requirements and expectations; support audits as required

• B.S. in Science field, or equivalent
Minimum 3 years’ experience in drug primary and secondary packaging experience
• Thorough working knowledge and experience in all aspects of Quality System Management (lot disposition, deviations, investigations, training, and auditing)
• Ability to effectively communicate verbally and in writing
• Ability to work with associates for various departments and levels to meet delivery commitments
• Ability to travel locally up to 25%
• Person-in-Plant experience preferred
• Minimum 3 years’ experience in Quality auditing in GMP environment preferred
Source: Job Diva – Job Listing

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