KS-LENEXA: Quality Assurance Assoc
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please visit http://sqa.fyicenter.com
Quality Assurance Assoc:
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.
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.
Qualified Candidates Must Have
o Bachelor's Degree in life sciences with a minimum of 2 years direct Quality Assurance experience or an equivalent combination of education and experience.
o An understanding of commercial Quality systems and the application of them in a manufacturing environment.
o Effective oral and written communication skills.
o Good customer service skills and the ability to negotiate win-win outcomes.
o Previous experience as an auditor of supplier products and services.
o 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.
o Quality Auditor Certification or the ability to obtain certification.
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Team SQAFYI - Software QA Resource FYI