Job Description
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
Qualifications
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)