Quality Assurance Specialist - East Windsor, United States - Aurobindo Pharma USA, Inc.

Description

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 < 5%


Education & Experience:

3+ years of experience in a GMP environment such as a Pharmaceutical Industry
Bachelor's Degree in chemistry, life sciences or related field with analytical laboratory experience a plus

Physical Requirements:
OFFICE POSITION - While performing the duties of this job the employee is required to: -Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment -Specific vision abilities required by this job include close vision requirements due to computer work -Light to moderate lifting is required -Moderate noise (i.e. business office with computers, phone, and printers, light traffic).

-Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.

Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.


Additional Physical Requirements:
No Additional Requirements


Blood/Fluid Exposure Risk:
Category


III:
Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.