Quality Assurance Specialist

3 weeks ago

Hightstown New Jersey, United States Aurobindo Pharma USA, 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:
This position provides support to various functions within Quality Assurance and reports directly to the Sr. Director of Quality Assurance. Responsibilities include the creation, organization, and review of GXP documentation, (e.g. change controls, specifications, protocols, SOPs and reports), and assisting with the coordination of training and budget activities, including purchase orders and invoices. The role assists QA product managers with responsibilities of overseeing contracted manufacturers and marketing partners, in an environment where all manufacturing/testing is contracted.  This role primarily consists of ensuring documents are formatted properly, well organized in our electronic repository and readily retrievable. The successful candidate will ensure documents provided to internal/external customers are accurate, clear, and in line with Acrotech SOPs. The Specialist will also help ensure that proposed changes consider the impact to other processes, documents, budget items and external partners through a full understanding of Acrotech’s processes. Based on a candidate’s knowledge and experience, the role may expand into other functions as well. The ability to assist with drafting clear SOPs is preferred. This role provides a unique opportunity to learn many aspects of Quality Assurance with a small company.

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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