Syngen Grede

About Syngen Grede

Technical Services/Quality Assurance Professional expertise in vendor management, product documentation, and quality driven process improvement in regulated environments (FDA, cGMP, ICH, WHO ISO9001:2015). I am Quality Assurance and analytical chemistry professional with progressive experience spanning pharmaceutical, biopharmaceutical, and regulated manufacturing environments. I lead technical documentation, supplier quality initiatives, raw material lifecycle management, and analytical testing across FDA, cGMP, ICH, USP, ISO 9001, and WHO‑regulated operations. I have streamlined cross‑functional processes and translated complex scientific and regulatory requirements into clear, customer‑ready solutions. I bring hands‑on expertise in advanced analytical instrumentation, CAPA investigations, metrology, vendor management, and specification development, and I partner closely with stakeholders to drive operational excellence, compliance, and continuous improvement.

Notable accomplishments:

· Reduced a backlog of more than 300+ tickets with response times over 3 months to fewer than 20 active tickets with sub‑3‑day turnaround by reorganizing the department’s queue and implementing systematic response workflows.

· Implemented structured Smartsheet tracking systems to monitor supplier/manufacturer changes, compendial product data, and critical quality documentation, improving visibility and control for 2000+ compendial graded products.

·  Slashed specification update meetings by 50-75% through standardized request processes and reviewer rubrics, enhancing workflow efficiency.

I’m currently exploring new opportunities in the pharmaceutical, biopharmaceutical, or highly regulated chemical industries, with a focus on Quality Assurance and Technical Services. I specialize in supply chain quality and CDMO quality management, and I’m always interested in connecting with professionals in these spaces.

Let’s connect!

1:1 Sessions

• SOP vs work instruction creation

  60 min

  1 on 1 help understanding if something should be an SOP or a work instruction.

  I can also help with writing and revising both types of documents.

  $50