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QA Compliance Specialist

Company: Aprecia Pharmaceuticals, LLC
Location: Cincinnati
Posted on: September 25, 2022

Job Description:

General Purpose of Position:
This position is primarily responsible for collaborating with all departments to help with coordination, creation, and implementation of processes and procedures to ensure that site quality compliance requirements are being followed at Aprecia Pharmaceuticals.

Primary Duties and Responsibilities (Essential Functions):





Duties/Responsibilities


1
Perform internal audits of all departments at Aprecias Blue Ash, OH facility


2
Organize the periodic Quality Management Review Committee meetings, compile slide decks provided by each department and participate in the discussions relating to evaluating the departments quality metrics and performance against those metrics


3
Perform external audits of suppliers and contract testing laboratories when required and maintain the Corporate Vendor Qualification program


4
Coordinate the issuance, tracking, approval and renewal of Quality Agreements with all vendors, as required


5
Lead the compilation of the Annual Product Reviews that analyze and assess all manufacturing, Quality Control (QC), stability, and other data related to our products and product changes


6
Maintain both a document management and change control system that align with FDA regulations (CFR, ICH, cGMP, GDP), quality, and Aprecia requirements


7
Perform new hire and annual cGMP training at Aprecia Pharmaceuticals


8
Support all requirements for Quality Systems (QS) documentation and perform back-up duties for Quality Systems, as required


9
Support the implementation and continuous operation of software applications


10
Investigate deviations against the document management system and establish robust corrective action plans



Assist with all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements


12
Other duties as assigned




Reporting to this Position:
No direct reports

Travel:
Position may require 10-20% travel

Work Shift:
This position works days

Knowledge, Skills and Abilities:


Strong oral and written communication skills
An understanding of cGMPs (current Good Manufacturing Practices) and FDA (Food and Drug Administration) pharmaceutical regulations
Well-developed interpersonal and problem solving skills
Excellent prioritization and organizational skills
Demonstrated ability to understand complex Quality issues and collaborate with other department to drive scientifically sound and compliant resolutions
Possess a keen understa

Keywords: Aprecia Pharmaceuticals, LLC, Cincinnati , QA Compliance Specialist, Other , Cincinnati, Ohio

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