Entry - level Quality Engineer at Celestica, responsible for quality standards in manufacturing processes. Engaging in ISO compliance, supply chain management, and process documentation.
About the role
- Senior Quality Assurance Specialist responsible for planning and executing QA deliverables. Overseeing technical quality and mentoring QA staff in clinical trial operations.
Responsibilities
- Develop, implement, and track compliance of QA plans (study, internal process and annual).
- Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders.
- Monitor, evaluate quality indicators, QA reports and audit responses.
- Support study operational teams with resolution of escalated issues.
- Identify quality GCP risks and work with leaders to design mitigation strategies.
- Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities.
- Act as a senior representative of Quality at internal and external meetings.
- Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics, and privacy inquiries.
- Remain knowledgeable and current on industry environment and regulatory legislation.
- Mentor other QA staff in the support of the development of standard operating procedures.
- Serve as a technical role model, motivator, and mentor to the members of the quality team.
- Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs.
- Develop and provide training both within the department and external to it.
Requirements
- Minimum of a bachelor's degree with 7-9 years of related experience and on the go training
- Fluent in English (verbal and written)
- Certification in Quality GCP or Auditing with strong written and verbal communication and presentation skills.
- Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred.
- Strong analytical, critical thinking and problem-solving skills required.
- Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.
Benefits
- Home-based
- Accommodations for job applicants with disabilities are available
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