QC Specialist

Evonik Group.; Burnaby; On-site; CAD 85,000 - 120,000; Full time

Job summary

Evonik在加拿大卑诗省本拿比招聘QC Specialist，负责QC运营计划、样品管理和测试活动，确保符合GxP与SOP要求。你将领导与客户项目相关的QC输入，制定并维护QC主计划，推动稳定性研究的测试安排，以及与内部团队和外部实验室的协调工作。

理想候选人具备化学/生物相关学位，5–8年药品质量控制经验，熟悉LEAN/Six Sigma等工具，具备良好写作与沟通能力，能够在快节奏、合规要求高的环境中管理多个项目并实现卓越运营。

Qualifications

• 具备化学/生化/微生物/应用科学等学位（BSc或MSc）
• 约5–8年药品质量控制或生物药领域经验，具备CDMO工作背景者优先
• 熟练使用项目管理/资源规划工具（LEAN、Six Sigma等）以推动运营卓越
• 优秀的文字写作、问题解决和沟通能力，注重数据准确性
• 能跨职能团队协作，具备自我驱动能力和灵活工作时间的适应性

Responsibilities

• 作为QC代表为客户项目提供运营 input
• 参与日常运营与项目会议，向项目管理和现场运营团队汇报QC进展
• 将QC行动计划转化为落地任务，确保按时交付
• 维护QC主计划/排程，包含资源分配和计划对齐
• 确保样品管理、测试活动符合SOP、GxP与EHSS要求
• 协调与客户、外部实验室及供应商的测试需求和时间表
• 参与稳定性项目的测试安排与数据管理

Job description

## QC Specialist申请: Burnaby, BC: 全职: 今天发布: R50791**我们提供** 在赢创(Evonik),您将成为一家活跃于全球的化工企业的一员,并在各大关键技术与行业的交汇处开展工作。无论是健康营养、低碳出行还是绿色能源——我们的产品正在改善人们的生活,惠及当下与未来。 根据我们的理念,成功并非单打独斗,而是源于多元化的思想和团队合作。无论是在自然科学还是工程领域,无论是职场新人还是拥有丰富经验的专业人士,无论是在业务、生产还是其他任何领域——我们彼此激励,不论挑战多么艰巨。加入我们,成为“特别的一部分(Part of Something Special)”! **欢迎了解我们丰富多样的福利待遇:** https://www.evonik.com/en/careers/why.html **在这里,您可以直接通过我们的员工了解更多关于赢创的信息:** https://www.evonik.com/en/news/meet-the-team.html**RESPONSIBILITIES**Leadership/ Functional:* Proactively collaborate with stakeholders of various functional groups to prioritize the work for QC to meet the business needs to achieve the best-in-class operation for a Contract Development and Manufacturing Organization (CDMO)* Be able to effectively influence QC team members to optimize the planning, daily and weekly QC schedules, and operational activities* Identify gaps and define implementation strategies to achieve operational efficiencies and improvementsOperational Excellence & Planning:* 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 updated to QC Manager* -Prepare/revise and manage the QC master schedule / plans (including QC resource allocation and planning) to ensure proper alignment with business plan and delivery schedules* Support the leading of the QC team to ensure all sample management and testing activities are performed efficiently and effectively, in accordance with approved SOPs, GxP requirements and expectations and EHSS requirements. Sample management includes cross-functional collaboration for RM sampling, arrangement of external testing, Utilities and Environmental Monitoring as well as proactive communication with those external labs regarding testing requirements and timelines for batch disposition.* Draft drug product specification & sampling plans* Ensure all stability projects are captured and maintained accurately in the QC system, which includes but is not limited to the following:* Prepare stability protocols accurately in accordance with the 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, includes but is not limited to:* Coordinate with Project Management to receive the reference standards from Clients* Coordinate the purchasing of the required reference standards* Accurately maintain the master list of reference standards; proactively manage the expiry/ re-test dating to assure adequate supply of standards are available for testing as per defined schedule* 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**您的申请** 为了确保尽快处理您的申请以及保护环境,请您通过我们的职业门户在线申请。作为雇主,您可以在www.evonik.com/en/careers找到有关赢创的更多信息。 请将您的申请发送给 Talent Acquisition Manager,说明您的最早入职日期和薪资期望。如有疑问或需要更多信息,可拨打Evonik Candidate Support 的电话:[phone]。