Supplier Quality Assurance Contractors (6 months) - Illinois
Proclinical is currently recruiting for a Supplier Quality Management/Supplier Quality Assurance consultant for a biotechnology company located in Chicago, IL. Successful candidate will contribute to Supplier Quality operations as they develop and maintain supplier quality standards to ensure their products are manufactured to relevant patient safety and product quality standards in line with business requirements.
- Plan, manage and support the conduct of supplier audits
- Manage existing suppliers in terms of periodic assessments and Quality Agreement maintenance
- Perform transactions for Supplier-related records and maintain data synchronization between suppliers and materials in company's various internal data systems
- Focal point for managing supplier quality related issues and supplier-related change notifications; Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers
- Provide clear communication (both verbally and orally) to all levels within the organization on quality related topics
- Undertake root cause analyses and identify solutions for supply chain issues. Ensure corrective and preventive actions are closed out by suppliers
- Work with the Purchasing team on new supplier introduction and approval
- Work within the cross-functional team to define criteria to ensure supplier process capability is effective to meet product and process requirements measure key supplier quality performance
- Support the Sr. Director of the department to monitor and report on supplier product quality and performance
Skills and Requirements:
- Bachelor's Degree required in a scientific discipline
- 10+ years of overall working experience in Biotech/Pharmaceutical industry, with at least 5 years of directly supporting the Supplier Quality Assurance functions is required
- Preferred experience in managing GCP/GPvP suppliers, third party logistics, transportation couriers and cold chain logistics
- Understanding of common biologics and sterile chemical materials manufacturing processes is strongly preferred
- Hands on knowledge of quality management and business systems for managing suppliers and materials is required
- Strong Knowledge of GMP (US, EU and APAC) as well as ISO standards with regards to material and service providers
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Ability to work in a diverse and dynamic environment
- Willingness to think outside of the box and adapt best practices to the growing environment
- Good communication and interpersonal skills
- Certification in PMP, CQA or ASQ is highly desired
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock at (+44) 203-078-9554 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Quality Assurance Specialist.