Quality System Specialist - Akkodis : Job Details

Akkodis is seeking a Quality System Specialist with a client located in Rochester, NY. Must hold a Bachelor's degree in a Engineering field to be considered. You will be responsible for conducting required Quality Assurance activities with local and global departments. Act as the lead for the maintenance of Packaging and Labeling QMS data and ensuring compliance to change control requirements for global processes and work with key business stakeholders through the Product Launch Process and Packaging Configuration approval.

Pay/Salary Range $30hr-$35hr.

Quality System Specialist job responsibilities include:

• Revise and at times create Standard Operating Procedures (SOP's), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts.

• Will utilize the electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training.

• Acts as the Quality Assurance representative and participates with cross functional teams on significant Packaging and Labeling projects (example. mass change for regulation update).

• Acts as the QA approver and change analyst for Packaging and New Product Launch Change Orders (PCO and NPLCO).

• Provides guidance and is the QA lead on process requirements to ensure compliance with change control regulations and policies and procedures.

• SME for Quality Assurance in both Global Processes.

• Acts as final QA review prior to execution of new product launch. Responsible for ensuring all requirements are met prior to final release.

• Lead in continuous improvement efforts to streamline the QA review in above mentioned processes.

• Acts as change analyst for Document Change Orders (DCO's) and any required Deviations for functional departments residing under the company's QMS at the site.

• •Reviews and participates in implementation of global document changes document required for the site.

• Regularly provides status and updates to QA Management regarding state of Packaging and Labeling QMS data and continuous improvement projects.

• Investigation, lead, coordinate, reviews and approvals of corrective and preventative action (CAPA) and nonconformance's (NCR).

• Assists with internal and process audits to verify conformance with standard operating procedures. This will include revising and or creating SOPs as needed. Conducts internal audits in any of the Rochester facility as required.

QUALIFICATIONS:

• Bachelor's degree in an Engineering field is required.

• Minimum Three years related experience.

• Experience Internal audits is required.

• Experience with ECO and CAPA's experience is required.

• Experience with documentation and/or technical writing experience is required.

• Quality Change Analyst is required.

If you are interested in this Quality System Specialist job in Rochester, NY then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Gina Manioci at 585-###-#### or [email protected]

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

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