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Job Description

The Quality Specialist I will provide analytical support in the Commercial and PDS Stability Teams by following standard practices. Performs scheduled pulls from ICH Stability Chambers, creates stability studies in LIMS Stability Module, stages samples in the stability chambers, writes/edits written stability protocols, performs annual chamber qualifications, schedules and supports chamber maintenance with outside contractors, supports Stability Supervisor with various other administrative tasks.

Essential Functions:

• Documents all Stability data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Independently carries out administrative tasks assigned by Stability Supervisor.
• Pulls scheduled stability samples from the ICH Stability Chambers following the LIMS Sample Pull List.
• Works Proficiency with MS Word & Excel Software.
• Must have ability to learn new systems quickly.
• Performs annual chamber qualifications and schedules/supports chamber maintenance with outside contractors.
• Independently edits/creates written stability protocols from documentation provided by Clients.
• Creates stability studies within the LIMS Stability Module and stages samples in the stability chambers.
• May be essential to perform alternating or rotating shift work (as required)

• Bachelors of Science in Chemistry or a related field. Equivalent combinations of education, training, and relevant work experience may be considered.
• 1-year previous related experience

• Comply with all Environmental Health & Safety Policies and Procedures.
• Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives.
• Carry out all duties within strict compliance to Patheon quality systems SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.
• Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared laboratory assets).
• Be always client and patient conscious.
• Understand Key Performance Indicators (KPIs) and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving.
• Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.
• Proactively identifies areas for improvement in the execution of analytical procedures. Communicate risks to timelines of deliverables in a proactive manner.
• Consistently strives to improve skills and knowledge in pharmaceutical development (an asset).

• Good understanding of basic chemistry and pharmaceutical industry.
• Good understanding of basic chemistry and some experience/knowledge of the pharmaceutical industry.
• Awareness of quality and willing to learn regulatory requirements essential to stability testing. Proficiency with the English language.
• Good problem-solving skills and logical approach to solving problems.
• Demonstrable interpersonal and communication skills (both oral and written).
• Ability to read and interpret technical procedures and governmental regulations.
• Ability to learn new systems quickly and work independently on tasks assigned.

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
• Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.