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