Person2Person, LLC
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| QA Associate Based in North Carolina |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Provide regulatory compliance and technical expertise, independent assessment and expert consultation.
Responsible for product quality and disposition for all products manufactured at Eisai and implementing
the quality systems associated with this function. The primary duties and responsibilities will include:
• Product Disposition (Commercial & Clinical)
• Deviations, Investigations and CAPA
• Product Complaints
• Controlled Document Assessment
• Participating in New Project Initiatives
• Compliance Assessments and Auditing
| REQUIREMENTS |
BS in a Science Related Field with 2-4 years QA in Pharma
Familiarity with Oral Solid Dose Manufacturing / Packaging
Experience with Performing and Writing Investigations (We have a ton of deviations that we need a very
experienced technical person who is familiar with the industry and can write a report, Risk
Assessments/Analysis)
Initiating CAPA (Corrective Action and Preventive Action) with regards to the Investigations
Experience with Customer Complaints, calling and writing the investigations. Understand Deviations and
Complaints, possibly written them and performed investigations. Good writing skills
Experience with Manufacturing and Packaging Batch Record Release of Commercial Products (i.e.
tablets, capsules, etc).
Product Disposition: - Review Batch Record to release to market. Review Packaging Record and make
sure they comply with procedures
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |