Specialist, Technical Writing

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.
The Specialist Technical manages the instrumentation and equipment in the QC lab including maintenance troubleshooting and coaching analysts on proper 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. May recommend the use of new and/or unconventional analytical techniques to enhance lab efficiency.
Make routine decisions around task consultation with higher level team members determines an overall assessment of instrument quality. 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.
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. Proper documentation and storage of analytical data.
May participate with peers across the organization as a member of a cross-functional project team. Provide coaching/assistance to chemists in proper operation and maintenance of instrumentation.
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.
Firm Knowledge with cGMP and Safety policies/procedures within the department/facility.
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
Fluent knowledge of Windows Microsoft Word Excel and Access Chemstation/Chemstore Empower Lab X instrumentation operating software or other suitable software.
Minimum 3-5 years of experience in chemistry or related field of study

We offer accommodation for applicants with disabilities as part of its recruitment process.