QC Specialist in Burnaby

At Evonik, you are part of a globally active chemical company and work at the interfaces of key technologies and industries. Our products improve people's lives today and tomorrow, whether in healthy nutrition, climate-friendly mobility, or green energy. We believe that success does not come from working alone but through diversity of ideas and teamwork.

RESPONSIBILITIES

• Proactively collaborate with stakeholders of various functional groups to prioritize the work for QC to meet business needs and achieve best-in-class operation for a Contract Development and Manufacturing Organization (CDMO).
• Effectively influence QC team members to optimize planning, daily and weekly QC schedules, and operational activities.
• Identify gaps and define implementation strategies to achieve operational efficiencies and improvements.
• Act as a QC representative to provide operational input for clients' projects.
• Attend routine operational and project meetings; provide QC progress updates to Project Management and the site operational team.
• Bring strategic/tactical plans into attainable QC actions to achieve on-time delivery of tasks and projects.
• Communicate status of QC activities to external stakeholders and project-related updates to QC Manager.
• Prepare/revise and manage the QC master schedule/plans to ensure proper alignment with business plan and delivery schedules.
• Support leading the QC team to ensure all sample management and testing activities are performed efficiently and effectively, in accordance with approved SOPs, GxP requirements, and EHSS requirements.
• Draft drug product specification & sampling plans.
• Ensure all stability projects are captured and maintained accurately in the QC system.
• Prepare stability protocols accurately in accordance with project requirements for internal and external review and approval in a timely manner.
• Ensure all stability samples are pulled and scheduled for testing within the defined timeframe.
• Support periodic inventory count of all stability samples performed by the assigned QC analyst(s).
• Perform peer review and approval of QC data related to testing of raw material, in-process, release, and stability materials.
• Support the team to assure all reference standards are received and managed accurately in accordance with site procedure.
• Participate in project(s) and temporary assignment(s) as assigned.

REQUIREMENTS

• BSc. or MSc. in Chemistry, Biochemistry, Microbiology, applied sciences or equivalent.
• Approximately 5 to 8 years of experience in the parenteral pharmaceutical or biopharmaceutical industry.
• Experience working in Quality Control is strongly preferred, with experience in project management, resource planning, and a CDMO environment as assets.
• Proficient in real-life application of various program management/resource planning tools (e.g., LEAN processes, Six Sigma, etc.) to drive operational excellence/efficiencies.
• Proven time management and organizational skills to work in a fast-paced, regulated environment and manage multiple projects concurrently.
• Demonstrated ability to think critically within applicable regulations for regulatory compliance and operational excellence.
• Excellent technical writing, problem-solving, and communication skills.
• Detail-oriented to assure accuracy of data and information.
• Effective and professional interpersonal skills with abilities to collaborate with others across multiple functions.
• Self-motivated with abilities to work in an undefined environment.
• Flexibility in work hours may be required.
• Proficient in computing (e.g., Microsoft Word, Excel, PowerPoint, Visio, etc.) and performing appropriate data analysis and risk assessment.