Senior Technician, Quality Systems & Compliance

Merck Merck · Pharma · NE

Merck is seeking a Senior Technician for Quality Systems & Compliance in Omaha, Nebraska. This role involves auditing, inspecting, and releasing incoming animal health pharmaceuticals, medical devices, and biologics according to cGMP standards. Responsibilities include managing inventory, ensuring cold chain adherence, performing physical inspections, handling Notification of Events (NOE) and Product Quality Complaints, and conducting investigations and CAPAs. The candidate must have experience with cGMP/GDPs and Data Integrity requirements, along with basic knowledge of USDA, FDA, DEA, and/or EPA regulations. A BS/BA in Biology or a related science is highly preferred.

What you'd actually do

  1. audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents as required.
  2. Manage short-dated inventory.
  3. Final compliant stock will be released for Distribution.
  4. Manage site Notification of Events (NOE) and Product Quality Complaints within the company's Reliance system, as required.
  5. Perform NOE follow-up and completion through investigations, Corrective Actions, Preventative Actions, etc., as applicable.

Skills

Required

  • Two (2)+ years of Quality Assurance / Quality Control experience.
  • Basic knowledge of USDA, FDA, DEA, and /or EPA requirements.
  • Good planning and organization skills to handle multiple projects.
  • Strong communications skills.
  • Technical writing skills.
  • Ability to assume technical responsibilities with minimum supervision.

Nice to have

  • BS or BA degree in Biology or related science

What the JD emphasized

  • cGMP/GDPs
  • Data Integrity requirements