MAIN PURPOSE OF ROLE:
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Ensure that the day-to-day activities of the Incoming Materials Laboratory are carried out in a safe and productive manner, adhering to GMP/GLP standards at all times.
MAIN RESPONSIBILITIES:
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Recommend revision of specifications when indicated.
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Formulate or assist in formulating quality control policies and procedures.
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Drive quality improvement and cost reduction using Six Sigma or Lean methodology.
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Supervise the day-to-day activities of the Incoming Material laboratory are carried in a safe manner.
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Knowledge of basic principles, methods, technologies and practices of a professional/technical field.
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General knowledge of procedures and activities within own work area.
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Focus on learning the key aspects and duties of the job being performed.
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Apply research, information gathering and analytical skills.
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Handle detailed and structured problems.
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Work on assignments where judgment is required a majority of the time.
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Work under general direction, seek assistance as needed.
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Contribute to own team/closely related teams through quality and accuracy of own output.
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Convey information in a concise and professional manner.
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Ask effective questions and solicits feedback to understand needs.
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Anticipates future needs based on past transactions.
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Working knowledge of GMP/GLP in medical device manufacturing, with emphasis on incoming materials handling and sampling.
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Computer literacy and experience with ERP and LIMS systems would be advantageous.
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Goal Setting Initiate.
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Troubleshooting/resolve and recommend.
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Planning Execute.
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Provide leadership within their shift, and sometimes lead projects across multiple shifts.
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Develop operational direction for immediate team.
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Conduct route cause analysis to determine root cause.
Accountability/Scope/Budget from Legacy System
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Adaptability.
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Innovation.
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Initiative.
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Teamwork.
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Integrity.
QUALIFICATIONS:
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Bachelor of Science Degree with minimum 1 to 3 years’ experience.
- 1 to 3 years’ experience in supervisory or relevant experience or equivalent combination of education and work experience.
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Leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
- Ability to understand and communicate sampling regimes and plans to inspectors, as well as work out ad-hoc sampling plans.
- Practical experience in working in a fast-pace laboratory environment with tight datelines and able to solve problems in a speedy manner.
