Sr. Specialist, Operations
MSDAbout the role
Job Description
Join our IPT Teams (Central Services, Warehouse and Packaging) as the Sr. Specialist of Operations in Elkhorn, NE! The Sr. Specialist will perform structured investigations and Root Cause Analysis to effectively communicate problems, causes and suggested corrective actions. The Specialist will review and audits manufacturing records for errors and ensure conformance to Quality standards and maintain company and Departmental standards and procedures.
Responsibilities Includes:
- Identifies and ensures appropriate solutions for records issues with help of manufacturing personnel.
- Revises documents to incorporate safety and quality improvements in manufacturing procedures.
- Performs sterile operations according to Standard Production Processes (SPPs) and Standard Operating Procedures (SOPs).
- May require contact with various hazardous materials, using appropriate Personal Protective Equipment.
Education Minimum Requirements:
Associate’s degree in a relevant scientific field (biology / chemistry, life science) with a minimum of four (4) years laboratory or related biologics and/or vaccine production experience -OR- Bachelor's degree in a relevant scientific field (biology / chemistry, life science, engineering) with a minimum of two (2) years laboratory or related biologics and/or vaccine production experience
Required Experience and Skills:
- Previous experience in Root Cause Analysis and Event Reporting in a manufacturing environment
- High analytical and logical problem-solving abilities
- Experience with document creation and formatting in Microsoft Office (Word, Excel).
- Skill in mathematical calculations and conversions
- Improvement-oriented
- Effective in communicating up and down organizational levels
- High standards with a strong work ethic
- Strong attention to detail
Preferred Experience and Skills:
- Working knowledge of cGMP and inventory control concepts strongly preferred.
- An understanding of aseptic techniques and procedures preferred.
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US and Puerto Rico Residents Only:
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