Senior Technician, Quality Systems & Compliance

Merck•Omaha, NE

23h

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. The candidate will audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents as required. This will include Batch Record reviews per cGMP as required. Manage short-dated inventory. Final compliant stock will be released for Distribution. Maintain completed inspection files. Adherence to medical product Cold Chain requirements will be addressed buy this candidate via on-line data downloading. The candidate will be responsible to perform physical inspections of incoming finished products, and approved artwork per AQL (Acceptable Quality Level) inspections. Manage site Notification of Events (NOE) and Product Quality Complaints within the company's Reliance system, as required. Perform NOE follow-up and completion through investigations, Corrective Actions, Preventative Actions, etc., as applicable. Assist in self-inspection audits for the Omaha Distribution Center. The candidate Must have experience with cGMP/GDPs and have understand Data Integrity requirements. Other Quality Assurance duties and projects will be assigned as applicable.

Requirements

High school diploma required.
3-5 years Quality Assurance / Quality Control experience.
Basic knowledge of USDA, FDA, DEA, and /or EPA requirements.
Must have good planning and organization skills to handle multiple projects.
Strong communications skills.
Technical writing skills.
Ability to assume technical responsibilities with minimum supervision.
Must have experience with cGMP/GDPs and have understand Data Integrity requirements.

Nice To Haves

BS or BA degree in Biology or related science highly preferred.

Responsibilities

Audit/inspect/release all incoming company Animal Health pharmaceuticals, third party pharmaceuticals, medical devices, third party biologic and diluents as required.
Batch Record reviews per cGMP as required.
Manage short-dated inventory.
Release final compliant stock for Distribution.
Maintain completed inspection files.
Adherence to medical product Cold Chain requirements via on-line data downloading.
Perform physical inspections of incoming finished products, and approved artwork per AQL (Acceptable Quality Level) inspections.
Manage site Notification of Events (NOE) and Product Quality Complaints within the company's Reliance system, as required.
Perform NOE follow-up and completion through investigations, Corrective Actions, Preventative Actions, etc., as applicable.
Assist in self-inspection audits for the Omaha Distribution Center.
Perform other Quality Assurance duties and projects as applicable.