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