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Specialist III, QA (Quality Systems / Trackwise)

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POST DATE 8/20/2016
END DATE 10/12/2016

Seqirus Holly Springs, NC

Holly Springs, NC
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Purpose:

Responsible for the development, maintenance, training and oversight of quality procedures and systems related to Change Controls, Deviations, Corrective and Preventative Actions, Adverse Events and Pharmaceutical Technical Complaints. Provides strategic and technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Policy requirements.

Major Accountabilities:

* Ensures that all aspects of USFCC Change Control, Deviation, CAPA, Adverse Events and Complaint operations comply with the requirements of the Seqirus Quality Policy and meets all relevant cGMP regulatory requirements

* Responsible for leading the continuous improvement of Quality Systems for QA oversight of manufacturing processes, QC laboratories, in-process sampling and control, quality systems and QA compliance. Responsible for the development and implementation of standard operating procedures (SOPs), training materials and supplemental documents governing management and usage of each quality system of responsibility as well as working collaboratively across the various functional areas to ensure understanding of the systems and consistent execution.

* Responsible for the implementation and use of the Trackwise computerized systems to support the Quality Systems Group

* Acquires and maintains knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the sites

* Participates as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams

* Active member of integrated operational team where interaction with various groups is required to coordinate, plan, and execute test work

* Responsible for analysis of data and identification of trends using computerized software such as Excel

* Serves as a leader in the organization in quality system of responsibility; may coordinate the daily operations of others

Minimum Requirements:

* Bachelor s degree in Science/Engineering discipline preferred or equivalent experience without degree.

* 8+ years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.

* Sterile product manufacturing knowledge and/or biopharmaceutical experience required.

* 3+ years of demonstrated experience with the development, maintenance, training and oversight of Quality Systems required

Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.