- This position will provide administrative, scheduling and maintenance of systems within the Quality Assurance Department. Key role in assisting with CAPA investigations and effectiveness. Participates in improvement projects and activities in the department to help meet plant goals in Quality.
Annual Document Review
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Ensures reassessments are being completed on time
Schedule/Assist with Monthly Sanitation Audits
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Ensure sanitation audit findings are closed on time
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Assist with internal auditor training
Schedule Monthly & Quarterly Quality Management System Review Meetings (QMSRM)
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Create and share agendas for monthly & quarterly QMSRM
- Compile all documentation associated with the QMSRM
- Present information for monthly & quarterly QMSRM
- Create and share meeting minutes for monthly & quarterly QMSRM
- Complete training for QMSRM items
Corrective and Preventative Actions (CAPA)
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Initiate Corrective Action Requests (CARs), Preventative Action Requests (PARs), and Supplier Corrective Action Requests (SCARs) as requested
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Maintain CAPA logs
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Collect updates related to CAPA status
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Ensure CAPA items are complete prior to closing
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Aid in root cause analysis, corrective actions, and determining effectiveness
Assist with QA compliance items
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Communicate items due each month
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Communicate status of compliance activities
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Ensure compliance calendar activities are complete each month
New Hire Training Document Control
- Process/file document changes (DCN’s)
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Ensure details such as revision number, document number, required approvers, and date are accurate
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Ensure training for all new/revised documents is complete when required
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Ensure master document logs are kept up to date
Continuous Improvement & Collaboration
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Participate in CI activities and improvement projects
Document Custodian (ICH Q7 Program, Where Applicable)
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Serve as the document custodian for assigned ICH Q7 Quality Management System (QMS) documents and records.
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Coordinate document formatting, routing, review, approval, issuance, revision, and obsolescence activities in accordance with document control procedures.
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Maintain document version control and ensure only current approved versions are available for use.
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Maintain document inventories, master document lists, and associated tracking logs.
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Coordinate periodic document reviews and follow up with document owners to ensure reviews are completed on time.
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Process document change requests and verify required approvals have been obtained prior to implementation.
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Archive and retrieve controlled documents and records in accordance with record retention requirements.
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Maintain training records and support training assignments associated with new or revised controlled documents.
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Provide document and record support during internal audits, customer audits, and regulatory inspections.
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Assist with document issuance activities and verification of document completeness, accuracy, and traceability.
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Support data integrity principles (ALCOA+) through accurate management and retention of quality records.
EDUCATION, CERTIFICATIONS AND EXPERIENCE:
- College Diploma/Degree or 3+ years related work experience required
- Must be PCQI certified
- Must have Food Defense Awareness training certificate
- Hazard Analysis & HACCP training certificate
KNOWLEDGE, SKILLS AND ABILITIES:
- Ability to work in team environment, but able to work alone on specific projects
- Good attention to detail and problem-solving skills
- Excellent oral, written and computer communication skills
- Understanding and application of Ajinomoto QMS policies, procedures, & job instructions
- Ability to use applicable software programs
- Must be willing to work overtime as needed
- Excellent networking skills and professional communication within the plant, within corporate, and with outside vendors.
