Senior Technician, Quality Systems & Compliance
Merck
12 hours ago
On-site
Omaha, NE
Operations
Responsibilities:
- Audit/inspect/release all incoming company Animal Health pharmaceuticals, third-party pharmaceuticals, medical devices, third-party biologics, and diluents as required (including batch record reviews per cGMP).
- Manage short-dated inventory; release final compliant stock for distribution.
- Maintain completed inspection files.
- Ensure medical product cold chain compliance via online data downloading.
- Perform physical inspections of incoming finished products and approved artwork per AQL.
- Manage site Notification of Events (NOE) and product quality complaints in the company’s Reliance system; complete NOE follow-up through investigations and CAPA.
- Assist in self-inspection audits for the Omaha Distribution Center.
- Perform other Quality Assurance duties and projects as assigned.
Qualifications:
- cGMP/GDP experience and understanding of data integrity requirements.
- High school diploma required; BS/BA in Biology or related science highly preferred.
Required Experience/Skills:
- 2+ years of Quality Assurance/Quality Control experience.
- Basic knowledge of USDA, FDA, DEA, and/or EPA requirements.
- Planning/organization for multiple projects; strong communications; technical writing.
- Ability to assume technical responsibilities with minimal supervision.
Benefits:
- Medical, dental, vision, other insurance benefits (employee and family); retirement including 401(k); paid holidays, vacation, compassionate and sick days.
Application instructions:
- Current Employees apply HERE; Current Contingent Workers apply HERE.
- Audit/inspect/release all incoming company Animal Health pharmaceuticals, third-party pharmaceuticals, medical devices, third-party biologics, and diluents as required (including batch record reviews per cGMP).
- Manage short-dated inventory; release final compliant stock for distribution.
- Maintain completed inspection files.
- Ensure medical product cold chain compliance via online data downloading.
- Perform physical inspections of incoming finished products and approved artwork per AQL.
- Manage site Notification of Events (NOE) and product quality complaints in the company’s Reliance system; complete NOE follow-up through investigations and CAPA.
- Assist in self-inspection audits for the Omaha Distribution Center.
- Perform other Quality Assurance duties and projects as assigned.
Qualifications:
- cGMP/GDP experience and understanding of data integrity requirements.
- High school diploma required; BS/BA in Biology or related science highly preferred.
Required Experience/Skills:
- 2+ years of Quality Assurance/Quality Control experience.
- Basic knowledge of USDA, FDA, DEA, and/or EPA requirements.
- Planning/organization for multiple projects; strong communications; technical writing.
- Ability to assume technical responsibilities with minimal supervision.
Benefits:
- Medical, dental, vision, other insurance benefits (employee and family); retirement including 401(k); paid holidays, vacation, compassionate and sick days.
Application instructions:
- Current Employees apply HERE; Current Contingent Workers apply HERE.