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Quality Assurance Associate I

2 months ago


Glasgow, United States Amneal Pharmaceuticals Full time

Description: Support and assist in the activity involving quality assurance functions, programs, and compliance within the Distribution and Transportation of product; including but not limited to Distribution Center"s product receipt, inspection, handling and release activities, and compliance with transportation quality requirements. Essential Functions: Review and Release of COC /COA for third party packagers, manufactures and business partners Provides technical support for the Kentucky site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal regulatory requirements and the company quality manual requirements Maintains the distribution center's environmental monitoring program and maintains proper program documentation. Maintains retain process Supports the customer returns process as defined in the related SOP. Follows proper procedures are followed for facility's pest control program and maintenance of the program's documentation Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site. Monitors Rework process Additional Responsibilities: Provides documentation pertaining to all quarterly internal audits Supports the development and implementation of standard operating procedures (SOP) and supplemental documents governing management and usage of each quality system of responsibility Perform all other tasks assigned by QA management Education: High School or GED - Required Experience: 2 years or more in Pharmaceutical QA / Warehouse / Operations Experience Skills: Considerable interpersonal skills are required to interact with various levels of internal and external customers - Intermediate Must be able to write and read in English - Intermediate Must possess the ability to prepare detailed and accurate documentation - Intermediate Good organizational ability and detail minded - Intermediate Ability to work independently on tasks - Intermediate Must be discreet with confidential information of which he/she has access. - Intermediate Strong ability to multi-task - Intermediate Specialized Knowledge: Strong knowledge of Microsoft Office software Must possess familiarity with FDA regulations as it relates to OTC drug products Working knowledge of Current Good Manufacturing Practices (cGMP) Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity