QC Technical Specialist(Contract)

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

The Specialist, Technical, manages the instrumentation and equipment in the QC lab, including maintenance, troubleshooting and coaching analysts on proper use.

Job Responsibilities

• Maximizes availability of analytical instrumentation. Accepts and processes Instrument Service Requests and their timely closure. Ensures instrumentation is available, in a calibrated / validated state prior to general lab use.
• Troubleshoots challenging technical problems for analysts / chemists as they arise and resolving the issue in house or using a service provider. Troubleshoot on instruments to determine what may be impeding analysis. Utilizes advanced analytical knowledge and experience in carrying out their investigation activities. May recommend the use of new and / or unconventional analytical techniques to enhance lab efficiency.
• Under guidance, resolves moderate issues and independently resolve basic issues with other departments and external contacts. Make routine decisions around task priorities. In consultation with higher level team members, determines an overall assessment of instrument quality. Generally seeks the input of higher level team members in more complex non-routine matters.
• Carrying out work related to instruments activities. Must develop and demonstrate an in-depth understanding of test methods / SOPs / compendia and Certificates of Analysis. Ensures work or advices complies with health and safety standards, SOPs, cGMP and regulatory requirements. When in a coaching role, ensures that all team members are aware of and complete their assignments in compliance with health and safety standards, SOPs, cGMP and regulatory requirements.
• Assisting, and training when required, chemists with proper operation of the lab instrumentation.
• In collaboration with coordinator, ensure proper maintenance, calibration, qualification and use of equipment. Participate in developing service provider contracts and the fulfilment by the service provider for said contracts. Summarizes, interprets and / or documents data / results.
• Reviews analytical data for accuracy and completeness as generated by team members.
• Ordering of new equipment / lab supplies and executing the IQ / OQ / PQ of the equipment within the AO / QC and AR&D departments.
• Writing, revising and reviewing SOPs and reports. Updates and maintains the master record of lab instrumentation.
• Proper documentation and storage of analytical data.
• Proper maintenance of laboratory by keeping it clean, tidy and safe.
• Involve in audits of Instrument systems and conducts appropriate follow-up investigations of issues arising from audit findings to determine root cause and suggest corrective action.
• May participate with peers across the organization as a member of a cross-functional project team. Need to have contact with external suppliers / service providers.
• Schedule calibrations / qualifications on designated instruments as required.
• Provide coaching / assistance to chemists in proper operation and maintenance of instrumentation.
• Ensure instrumentation is available, in a timely manner, in a calibrated or qualified state prior to general lab use.
• Make reports about the progress made in the lab.
• 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

Knowledge, Skills and Abilities Firm Knowledge with cGMP and Safety policies / procedures within the department / facility.

Familiar with USP, BP, EP and ICH guidelines and procedures and key terminology

Knowledge of operating and troubleshooting instruments such as GC, HPLC, UV, IR

Knowledge with USP, BP, EP and ICH guidelines and procedures.

Proven record of analytical skills and knowledge of using GC, HPLC, UV, IR, DSC, KF, etc.

Documentation is neat and concise.

Highly organized, detail oriented and efficient individual able to readily react to a fast paced work environment, with the ability to multitask and balance changing priorities

Ability to work as a member of a team

Proficient in troubleshooting instruments.

Ability to follow SOPs.

Conducts themselves in a fashion that is consistent with the safety fundamentals of a laboratory.

Fluent knowledge of Windows, Microsoft Word, Excel, and Access, Chemstation / Chemstore, Empower, Lab X, instrumentation operating software, or other suitable software.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.