QA Support Coordinator

Quality Control | Warminster, PA

Job Description:

Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company, is a leading manufacturer of recombinant proteins. Our vision is to provide a superior and affordable source of recombinant proteins to the academic and industrial scientific research communities. Our team are a passionate group from diverse backgrounds. Our headquarters and state-of-the-art, manufacturing facility is located in Warminster, Pennsylvania. Founded in April 2006, we joined Fujifilm Group in March 2022 and are rapidly expanding our operations.

At Shenandoah, rather than strive to be the largest, we strive to be the best.  We are compassionate in our work, driven by integrity and dedicated to a superior standard of excellence.  It is important to us to create a working environment for our employees that is filled with respect, humor and gratitude so we can give our very best to our customers.

We are hiring a QA Support Coordinator. The Coordinator works with Quality management to coordinate and complete Quality System information requests, deviations, process improvements, projects, and other Quality related activities.  Use techniques of project management, quality improvement, outcomes, and measurement to fulfill the requirements. Performs the activities for external and internal requests for quality information.  Assists with batch record review, raw material inspection and/or other tasks as required. Coordination of quality process outputs and actions.  Ensure that customers obtain needed information to continue their process.   Act as customer voice as needed. Ensure compliance for these tasks as prescribed by the FDA's GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, and Health Canada SOR.

Responsibilities:

  • Coordinates any activities/actions related to various Quality systems processes.
  • Assist with NCR/Deviation management and completion of their activities
  • Responds and fulfills customers' requests for information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc.)
  • Acts as customer liaison for internal inquiries and provide voice of customer
  • Completes customer surveys and questionnaires completion
  • Assist with supplier questionnaires, qualification and certification
  • Assist with customer audits and manage follow up action completion
  • Assist with change notification and supplier management
  • Assist with batch record review, product inspection, and receiving inspection as needed 

Experience/Education:

  • High school diploma or equivalent; basic understanding of mathematics
  • Two years of college in a science discipline is preferred
  • A minimum of two (2) years of Quality Assurance, preferably in medical device manufacturer or equivalent
  • Proficiency in current versions of MS Word, Excel, Outlook, PowerPoint
  • Strong communication/project management skills
  • Excellent written and oral communications
  • Excellent computer skills including MS Word, Excel, PowerPoint
  • Ability to speak, read, and write proficiently in English
  • Good oral and written communication skills

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Principals only. No recruiters please.

Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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