Quality Document Control
About the role
Additional Information
All your information will be kept confidential according to EEO guidelines.
Company Description
Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com.
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