Senior Officer, Stability Lab (Documentation)

Job Summary

Coordinates sample flow and testing of samples within PD Solid Dose laboratories.  Maintains inventory and records related to samples used in the labs.

Job Responsibilities

• Receives, logs and tracks lab samples, requesting these samples from other departments or external sources as required.
• Log Raw Material, Semi-Finished, and Finished Product samples in LIMS as required.
• Perform SAP requisitioning, and place laboratory purchase orders as required.
• Maintains records for all Controlled and Targeted Substances (CTS) substances as per established procedures.
• Provide sample package (placebo, standards, samples, documentation, etc.) to the labs for testing.
• Coordinates with external testing laboratories on API and excipient testing as needed.
• Interacts with Product Development colleagues (e.g. Formulation Development, Analytical Laboratories etc.) to coordinate and help prioritize API, Excipient and batch testing.
• Plans and prioritizes work to align with project timelines, seeking input from team members (e.g. Analytical Development, Formulation Development, and Project Management etc.). Monitors status and recommends changes when needed to meet customers’ needs.
• Receives and tracks in-process and finished product samples from Formulation Development and coordinates with Analytical Laboratories for completion of the requested testing.
• Provides status updates to team members as needed.
• Evaluates sample / material flow processes and recommends changes or improvements where needed.
• Ensures that the work is done in full compliance with Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Documents, and established safety standards.
• Resolves routine issues with internal customers, working with more senior team members for guidance as needed.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate 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
  • A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Excellent oral and written English communication skills.
  • Strong organizational and interpersonal skills.
  • Strong customer service focus.
  • Familiarity with Microsoft application software, proficiency in SAP and LabWare LIMS is an asset.
  • Strong ability to work efficiently in a team environment.
• Experience
  • Minimum 1-2 years relevant experience.