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Supervise, lead and mentor staff including ongoing coaching, performance feedback and reviews, routine meetings, standard hours, collaboratively identifying objectives and career development
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Ensure staff are working in a safe environment and are complying with safety procedures at all times
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Responsible for overall day-to-day operation of the lab
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Plan, schedule, organize and monitor workload optimally to ensure all operations and tasks are performed within required turnaround time metrics and adherence to set schedules, accommodating testing requirements and meeting departmental goals
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Author risk assessments and reports for Nitrosamines, Elemental Analysis and Residual Solvents evaluations
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Act as the Lab Manager back up if needed
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Investigate and documents discrepancies where required.
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Provide troubleshooting of test method and equipment issues.
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Responsible for full-cycle internal lab investigations, including trending and preventative actions.
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Work closely with and perform follow-ups with Purchasing, Vendor(s), Materials Management, Warehouse, R \& D and the QA Department
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Establish and maintain a tracking mechanism to monitor daily requirements
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Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements
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Create, review and write procedures
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Review current systems and procedures and implement changes where appropriate to improve productivity
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Provide analytical instrumentation support to the lab staff
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Participate in Internal, Customer and Regulatory Audits
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Partner with Warehouse and Purchasing to proactively build quality into the processes and systems
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Automates job functions to achieve efficiency improvements
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Perform monthly Health and Safety Audits and safety awareness training
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Respond to Health and Safety audit reports
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Other responsibilities and special projects as required
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Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
