CincinnatiOHRecruiter Since 2001
the smart solution for Cincinnati jobs

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):


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

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

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

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

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

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

Perform new hire and annual cGMP training at Aprecia Pharmaceuticals

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

Support the implementation and continuous operation of software applications

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

Other duties as assigned

Reporting to this Position:
No direct reports

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest Ohio jobs by following @recnetOH on Twitter!

Cincinnati RSS job feeds