Position:  Microbiology Coordinator
Location:  Cantanhede, Portugal
Job Id:  1594
# of Openings:  1

Microbiology Coordinator
Cantanhede 
Portugal 
 
Tilray is a global leader in medical cannabis research and production dedicated to providing safe, consistent and reliable therapy to patients. We are the only GMP certified medical cannabis producer currently supplying products to thousands of patients, physicians, pharmacies, hospitals, governments and researchers in Australia, Canada, the European Union and the Americas.  Our team of PhD scientists, botanists and master horticulturists are leaders in cannabis research and related agricultural sciences. We strive to improve scientific understanding of the potential applications of medical cannabis and have invested in developing continuing medical education programs for health care practitioners around the globe.


Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference

 
 

Reporting to the Quality Control Manager, the Microbiology Coordinator will be responsible for the coordination of microbiology lab work to ensure the successful implementation of Tilray Microbiology Lab in order to achieve regulatory compliance and business goals.  The Microbiology Specialist will work closely with production, manufacturing, maintenance and facilities to ensure that micro quality standards are established, implemented and maintained throug all operations. The Microbiology Coordinator will improve quality inspection, monitoring and other in-house processes with the objective of constant improvement of quality processes. Microbiology needs to be articulated with the rest of quality control lab activities.

Role and Responsibilities

  • Develop, implement, and maintain microbiology lab work/methods to ensure product quality and/or regulatory compliance;
  • Coordinate purchase of equipments, consumables and reagents as required;
  • Ensure the in-house implementation of environmental monitoring of GMP areas for the detection of viable particles;
  • Ensure the in-house implementation of microbiological test for finished product;
  • Ensure the in-house implementation of microbiology monitoring of clean utilities (compressed air, nitrogen, water, etc…).
  • Ensure in house testing support for cleaning validation, process validation and in-process control as required;
  • Ellaboration and revision of QC SOPs, test methods, test records to ensure compliance with regulatory requirements;
  • Risk Assessment Analysis;
  • Ellaboration and revision of protocols and reports;
  • Review all microbiology related data for compliance to Portuguese legislation and Eudralex Vol 4 GMP guidelines and lead corrective action required;
  • Prepare and review certificates of analysis;
  • Perform GMP audits, monitoring and communicate non-compliances and collaborate with respective departments on corrective actions;
  • Support management of the Change Control System, Validation System and Deviation Investigation Reports (DIR), including Root Cause Analysis (RCA), Corrective and Preventative Action (CAPA). Ensure all reports are completed in timely manner;
  • Lead laboratory investigations (OOS/OOT);
  • Ensure adequate trendings as required;
  • Monitor the performance of employees within department;
  • Ensure adherence to all policies and compliance with GMP documentation, Good Laboratory Practices in all laboratory operations;
  • Maintain a safe, clean and legally compliant workplace;
  • Identify, investigate, correct and document potential quality and compliance issues;
  • Establish methods to meet work schedules and co-ordinate work activities, with other departments;
  • Resolve work problems and recommend measures to improve productivity and product quality;
  • Motivate members through the setting of clear expectations;
  • Coordinate with other supervisors, leads, and managers to obtain maximum use of resources;
  • Plan for manpower and equipment needs according to schedule;
  • Ensure compliance with company standards for cost control, waste reduction, quality, safety, and complete and on-time delivery;
  • Provide leadership for problem and conflict resolution;
  • Identify and determine quality and productivity related problems and solutions;
  • Coordinate and oversee employee work assignments and special projects;
  • Maintain and adhere to all company policies and procedures;
  • Perform other tasks as may be assigned.

Qualifications 

  • Post-Secondary Degree required in a related field (Bio-Science, Microbiology, Pharmacist, etc);
  • Five years of work experience in a GMP environment with a microbiology focus;
  • Strong GMP compliance experience;
  • Full Time Availability;
  • Knowledge of English language (spoken and written) is required;
  • Proven expertise related inventory management systems;
  • Proven ability to effectively use Microsoft Office Applications;
  • Strong inventory and production management skills required;
  • Must possess excellent communication skills for liaising and communicating staff, vendors, and other departments;
  • Highly capable of multi-tasking, with minimal supervision;
  • Extremely detail-oriented and analytical thinker;
  • Able to interface directly with cross functional teams;
  • Able to develop, review, and maintain metrics and audits;
  • Proven problem identification skills;
  • Good writing skills;
  • Strong work ethic and positive team attitude. 

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