Senior Technician, Quality Systems & Compliance

MSD • Omaha, NE

2d • Onsite

About The Position

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.
• Two (2)+ years of Quality Assurance / Quality Control experience.
• Experience with cGMP/GDPs.
• Understanding of Data Integrity requirements.
• 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 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.
• Perform Batch Record reviews per cGMP.
• Manage short-dated inventory.
• Release final compliant stock for Distribution.
• Maintain completed inspection files.
• Adhere to medical product Cold Chain requirements via on-line data downloading.
• Perform physical inspections of incoming finished products and approved artwork per AQL inspections.
• Manage site Notification of Events (NOE) and Product Quality Complaints within the company's Reliance system.
• Perform NOE follow-up and completion through investigations, Corrective Actions, Preventative Actions, etc.
• Assist in self-inspection audits for the Omaha Distribution Center.
• Perform other Quality Assurance duties and projects as assigned.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED