Job Description
SAFC Biosciences, a Sigma-Aldrich Company, is a preferred supplier of critical raw materials, specialty products and services for cell culture manufacturing in the global healthcare industry.
Job Description:
1. Review and release raw materials in a timely manner, assuring any lot deviations and Out of Specifications (OOS) are completed and closed.
2. Answer questions from internal and external customers.
3. Label approval, label generation, and review of daily QA paperwork to include charts, monitoring exhibits, and environmental records.
4. Review batch records prior to production.
5. Review and release finished products in a timely manner, assuring any lot deviations are completed and closed.
6. Lead cross-functional deviation investigations, root cause analysis, and CAPA plan development in a timely manner. Maintain CAPA tracking and perform effectiveness check as applicable.
7. Maintain Quality Systems and Quality System Metrics.
8. Participate in customer and ISO audits including opening/closing meetings, tours, document review and any follow-up activities, as necessary.
9. Perform audits of suppliers as required by SAFC Biosciences policies. Inform suppliers of audit observations and any follow-up activities as necessary.
10. Conduct periodic internal audits to meet regulatory requirements on a regular basis.
11. Approve master batch records and batch records, assuring accuracy and completeness. Resolve any discrepancies in documentation.
12. Review and approve SAFC Biosciences product and customer product specifications.
13. Takes part in and contributes to a safe working environment by following corporate and departmental safety regulations.
14. Perform new hire, ISO, and GMP training.
15. Maintain Site Quality filing systems as necessary.
Job Requirements
Qualified Candidates Must Have
Bachelor's Degree in life sciences with a minimum of 2 years direct Quality Assurance experience or an equivalent combination of education and experience.
An understanding of commercial Quality systems and the application of them in a manufacturing environment.
Effective oral and written communication skills.
Good customer service skills and the ability to negotiate win-win outcomes.
Previous experience as an auditor of supplier products and services.
Preferred
More than 2 years experience in a Pharmaceutical, Supplier or other Healthcare industry with demonstratable familiarity of cGMP's, cGLP's and/or related ISO requirements.
Quality Auditor Certification or the ability to obtain certification.
Sigma-Aldrich is a leading Life Science and High Technology company. Its chemical and biochemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 38 countries and has 7,900 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Innovation and Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit its award-winning Web site at http://www.sigma-aldrich.com.
Sigma-Aldrich offers a highly motivational and rewarding working environment with attractive salary, benefits, retirement, relocation and incentive packages including tuition reimbursement. Sigma-Aldrich fosters the growth of employees in a culture of respect and dignity with ample opportunity for career advancement.
Sigma-Aldrich is an Equal Opportunity Employer
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