Sr. Specialist, Quality Compliance & Doc Control at The Judge Group Inc. in Philadelphia, Pennsylvania

Posted in Other 11 days ago.





Job Description:

Location: REMOTE

Description: Our client is currently seeking a Sr. Specialist, Quality Compliance & Doc Control


We are seeking a Specialist, Quality Assurance for a position based out of Norwood, MA *THIS IS A REMOTE ROLE BUT WILL REQUIRE ON-SITE TRAINING* . The individual in this role will be responsible for providing Quality Assurance (QA) Documentation support for an External QA team. The individual will primarily work with colleagues in External Quality as well as with Supply Chain Operations and logistics, Internal QA, and external Vendors to provide quality documentation support. This individual will support external QA by helping manage documents in the quality document management system, assist in collecting and archiving documentation and support certain quality system activities. Additionally, the individual will track and populate systems to maintain metrics and trends. The successful candidate must have experience in managing documents in a quality document management system.



This job will have the following responsibilities:





  • Review, approve and archive certain documents into the quality management system

  • Collect, record and archive documents in support of the external QA team

  • Report on pending documents and help support retrieval of hard copy documents needing archiving

  • Provide any other documentation support needed to ensure External QA is audit ready

  • Track Quality Systems including Change Controls and Deviations within systems as well as at CMOs


Qualifications & Requirements:
  • BS degree with at least 6 years of Quality assurance experience in pharmaceutical industry providing Quality Assurance oversight OR 4 years of experience with MS degree

  • Outstanding / effective communication skills (verbal and written)

  • Ability to manage multiple projects in a fast-paced environment

  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment

  • Experience in the drug manufacturing and/or drug packaging and labeling processes

  • Experience in SAP or similar ERP system

  • Strong experience in Quality Document Management Systems including records and quality events

  • Proficiency in Microsoft Office tools including Powerpoint, MS Project and Visio

  • Previous experience in a GMP environment is required




Contact: tpendergast@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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