Quality Document Control

Job Description

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

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

Qualifications

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.

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

Additional Information

All your information will be kept confidential according to EEO guidelines.