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Quality Coordinator (Incoming Material Inspection)
Ref No.: 18-12117
Location: Lincoln, Nebraska
Start Date / End Date: 09/17/2018 to 09/13/2019

Job Title: Quality Coordinator (Incoming Material Inspection)
Hours: 7:30 am - 4:00 pm; Monday – Friday (1st Shift)


New Added Details:
-
Review, change and release inspection plans within the Laboratory Information Management module in SAP
- Build new Inspection Plans within the SAP system

Position Responsibilities
• Compile documents and supporting documents for biological and pharmaceutical raw material receipts
• Perform preliminary review of documentation and specifications
• Update controlled documents (internal and registered) as needed to support area functions
• Update SOP's (standard operating procedures) and related documents as needed to support the Quality Operations Team
• Raw material sample handling and archival
• Perform back-up admin duties.
• Verify and record results and/or disposition in the laboratory information management and enterprise resource planning (LIMS/ERP) systems
• Collect/track documentation requested during audits.
• Assist with other activities as requested, including, but not limited to use/support of Quality Systems (both Quality Tracking and Laboratory Information Systems)support of annual product review, risk assessments, change control, supplier management, stability program
• Perform other duties and special projects, as assigned

Education and Experience
2 year Associates degree in Chemistry, Biology or related field or equivalent post-secondary education or a minimum of 2 years relevant work experience with material disposition, laboratory testing, LIMS or MRP/ERP computer systems and/or regulatory documentation
Experience with incoming inspection of raw materials within the Pharmaceutical industry preferred.

Technical Skills and Competencies
Required Candidate Qualifications:

• Some working knowledge of US-FDA, EU and International Registration requirements
• Demonstrated strong technical systems skills
• Proficient in Word and Excel Microsoft applications
• Strong organization skills with proven experience in multi-tasking and prioritizing projects
• Process and detail oriented with the ability to follow complex processes and prepare detailed structured documents
• Demonstrated organizational and administrative skills and the ability to communicate effectively with multiple organizations

Preferred Candidate Qualifications:
Experience in change management processes, manufacturing/quality operations, laboratory and/or regulatory affairs
• Experience with Training Documentation Systems, Quality Tracking Systems, Laboratory Information Management and Manufacturing Resource Planning Systems (SAP), Microsoft Office applications