ESSENTIAL DUTIES AND RESPONSIBILITIES:
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Conduct various Quality audits and inspections.
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In-process
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Line audits
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Start-ups and changeovers
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Finished Goods
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Trailers
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Incoming raw materials.
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GMP Audits
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Identify and report any nonconformances and process deviations.
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Maintain cGMP compliant documentation of Production and Quality records.
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Assist with Stability, Reserve, and USP Sampling Programs.
- Review guidance and documents as directed for alignment with current processes.
- Observe processes for reporting systemic improvement opportunities.
- Complete and submit Laboratory Requests.
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Collect Environmental monitoring data.
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Review Daily Batch Records and other Quality records for GDP errors and GMP compliance.
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Identify and place any non-conforming material or products on Quality Hold. This will include physical placarding, quarantining and system Quality Holds.
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Assist with product returns and make appropriate notifications.
- Maintain cleanliness and organization of all Quality areas.
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Maintain Quality Hold Logs and the Disposition of products.
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Data Entry (Logbooks and Spreadsheets)
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Assist Supervisor with maintaining Daily Compliance Logs.
- Will coordinate with training staff to educate employees on Good Manufacturing Practices, Good Documentation Practices, and Safety & Housekeeping Policies. Assist Production Supervisors and the Training Dept. with employee training.
- Maintain and organize Document/Record Storage.
- Report observations of unsafe working conditions to management.
EDUCATION and/or EXPERIENCE:
- Minimum Education Details:
- High school diploma or GED
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No prior experience required however prior experience is preferred
Work will take place primarily in a warehouse and manufacturing environment. Employees may be required to work weekends, holidays and be on-call, on occasion. The employee may encounter uncontrolled air conditions with frequent air changes and environmental exposure.
These are considered essential duties and are illustrative of those job tasks, which are fundamental. Employees may be required to perform additional related duties as they may be assigned by management. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
