Specialist, Technical Training and Support

Job Summary

The Specialist, Technical Training and Support role is a senior technical position within the Global Microbiology team functioning as an expert resource in microbiology across the organization.

Keeping abreast of regulatory / industry standards pertaining to microbiology, the incumbent will support the efficient incorporation of international regulatory and compendial requirements with regard to microbiological testing methodologies and specification development ensuring that the Apotex Global Microbiology network remains compliant.

The Specialist, Technical Training and Support will develop training curricula to ensure microbiology personnel meet the expectations for job performance, execute and monitor the effectiveness of training programs.

Job Responsibilities

• Serves in a technical role providing guidance to other team members within the Global Microbiology networks.
• Provides technical support to Research and Development/Formulation Development with regard to microbiological methodologies and analyses. Establishes microbiological specifications for both finished product and raw materials.
• Leads/coordinates, in collaboration with the Global QC LIMS Ops & Support the development and update of LIMS Microbiology testing templates supporting the global microbiology operations.
• Investigates and resolves deficiencies from regulatory agencies across the globe on behalf of all Apotex sites.
• Responsible for microbiology related training programs on a global level, including technical training, microbiologist certification and LIMS training:
  • Develops training curricula and assesses the ongoing effectiveness of the material.
  • Delivers training.
  • Assesses the competency of the trainee.
  • Monitors the effectiveness of the training programs.
• Resolves moderately complex issues with external, internal customers and suppliers.
• Serves as the main contact with third party laboratories and ensures that subcontracted work is conducted in full compliance with GMP, SOPs and other regulatory standards.
• Keeps the next level of management conversant with regulatory amendments pertaining to the department and associated testing methodologies by maintaining current awareness and keeping abreast of compendial changes (both domestic and international as they pertain to microbiology).
• Liaises with and develops a rapport with regulatory and compendial agencies.
• Supports activities of internal and regulatory inspections and assists in the completion and follow-up activities on a global level.
• Collaborates with members of cross-functional teams to drive projects.
• Identifies process inefficiencies, establishes root causes of problems and offers resolutions.
• Summarizes and interprets the more complex microbiological data.
• Demonstrates a strong technical written ability. Drafts protocols and technical studies.
• Develops, qualifies and implements new test methods and procedures.
• Provides support in the validation of complex microbiological methods.
• Demonstrates personal leadership attributes through commitment to ongoing professional development and continuous learning.
• Acquires and maintains a level of basic knowledge of related areas by attending training courses, including in-house classes and industry seminars.
• Works independently to provide high quality results.
• Independently performs multiple tasks to meet tight deadlines in a fast-paced environment.
• Works in a safe manner collaborating as a team member to achieve all outcomesDemonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum B. Sc. in Microbiology, or closely related field.
• Knowledge, Skills and Abilities
  • Able to interpret results and perform work independently with minimal direction.
  • Sound understanding of established compendial and regulatory requirements. (Domestic and international).
  • Excellent communication skills, written and oral.
  • Good computer skill with prior experience working with applications such as LIMS, Trackwise, SAP.
  • Detail oriented with excellent problem solving skills.
  • Proven organizational and time management skills, as demonstrated through previous work and/or educational experience.

• Experience
  • Minimum 5 years’ experience in pharmaceutical microbiology.