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