Quality Specialist

The Quality Specialist ensures all the products and services offered are of the highest

quality in terms of satisfaction, predictability, and sustainability

Responsibilities

• Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and SOP requirements.


• Monitor schedule for production priorities.


• Review of completed batch record for conformance with cGMP and ensure that any changes are performed according to procedures.


• 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.


• Working with client on release of material and any questions related to batch records, complaint and deviations.


• Release batch within MRP System


• Record and track errors and right-first time to maintain departmental metrics.


• Archive batch documents onto shared drive and within archive room.


• Ensure that responsibilities are completed efficiently while maintaining Quality.


• Communicates PSQDC counter measures and safety issues to Quality Management.


• Complies with EH&S and 5S requirements for QADC.

*SHIFT: 9am – 5:30pm including lunch, onsite in Malvern, PA

• B.S. / B. A. Degree strongly preferred plus a minimum of 3+ years’ experience in the pharmaceutical industry including a working knowledge of GMPs.


• Superior written and verbal communications skills


• Excellent command of the English language and grammatical application thereof


• Keen attention to detail


• Highly organized


• Proficient with MS Word, including TOC, creating/using styles, footnotes, and cross references


• Competent with MS Excel, PowerPoint, and Outlook