MAIN PURPOSE OF ROLE:

• 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:

• Recommend revision of specifications when indicated.
• Formulate or assist in formulating quality control policies and procedures.
• Drive quality improvement and cost reduction using Six Sigma or Lean methodology.
• Supervise the day-to-day activities of the Incoming Material laboratory are carried in a safe manner.
• Knowledge of basic principles, methods, technologies and practices of a professional/technical field.
• General knowledge of procedures and activities within own work area.
• Focus on learning the key aspects and duties of the job being performed.
• Apply research, information gathering and analytical skills.
• Handle detailed and structured problems.
• Work on assignments where judgment is required a majority of the time.
• Work under general direction, seek assistance as needed.
• Contribute to own team/closely related teams through quality and accuracy of own output.
• Convey information in a concise and professional manner.
• Ask effective questions and solicits feedback to understand needs.
• Anticipates future needs based on past transactions.
• Working knowledge of GMP/GLP in medical device manufacturing, with emphasis on incoming materials handling and sampling.
• Computer literacy and experience with ERP and LIMS systems would be advantageous.
• Goal Setting Initiate.
• Troubleshooting/resolve and recommend.
• Planning Execute.
• Provide leadership within their shift, and sometimes lead projects across multiple shifts.
• Develop operational direction for immediate team.
• Conduct route cause analysis to determine root cause.

Accountability/Scope/Budget from Legacy System

• Adaptability.
• Innovation.
• Initiative.
• Teamwork.
• Integrity.

QUALIFICATIONS:

• 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.
• 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.