Quality Assurance Specialist

2 weeks ago


East Windsor, United States Acrotech Biopharma Inc Full time

Division Overview:
Acrotech Biopharma Inc., was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research based organization that strives to launch treatments which are accessible to patients that need them.

Job Overview:
**Responsibilities**:

- Organize documentation and ensure ease of identification and retrieval
- Assist in the issuance of purchase orders, invoices, and budget development
- Assist managers in the organizing, maintenance, writing and review of GxP documents related to products, production, and CMO/CTO (contractor) oversight
- Consolidate and review documents to prepare for and/or release product, including: Certificates of Analysis, Certificates of Conformance, Test and Batch Record Review Forms, investigations and change controls
- Assist the review of i deviations, complaint investigations and change controls
- Author/Review SOPs & specifications
- Compile final documents related to batch production and release
- Assist with tracking the stability & reference standard programs at contractors
- Consolidate documentation/data for Annual Product Reviews (APRs) and trend stability data
- Track activities and support the creation of monthly metrics
- Technical Support for marketing partners
- Support client/regulatory audits/inspections and requests for documentation
- Perform additional duties as assigned by department management

Qualifications - Skills & Requirements:

- Attention to detail; well organized
- Excellent communication skills - able to communicate clearly and concisely
- Strong computer skills, including proficiency with MS Word, Excel, PowerPoint, and Outlook. Skills in Visio, SharePoint, and Oracle a plus
- Domestic and international travel possible



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