My name is Deidra and I represent The Fountain Group. We are a national staffing firm and are currently seeking a QA Specialist III for a prominent client of ours. This position is located in Holly Springs, NC. Details for the positions are as follows:
· Responsible for the development and maintenance of quality procedures and systems related to Quality Assurance oversight.
· Provides strategic and technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMP's, legal, regulatory requirements, and the V&D Quality Manual requirements.
· Ensures that all aspects of USFCC operations comply with the requirements of the V&D Quality manual and meets all relevant cGMP regulatory requirements
· Responsible for the development 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) and supplemental documents governing management and usage of each quality system of responsibility
· Responsible for the implementation and use of computerized systems to support the Quality Systems 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
· 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
· Team is responsible for Quality Systems including deviation review and approval, change control management and Product Technical Complaints.
· Ideal candidate will have extensive experience with Trackwise Sentry system including Deviation and Change Control management
· Bachelor's degree in Science/Engineering Discipline required
· Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.
· Sterile product manufacturing knowledge and/or biopharmaceutical experience required.
If you are interested in hearing more about the position please respond with your resume attached.
About The Fountain Group:
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
The Fountain Group was founded in 2001 with the mission of providing quality resources to businesses on a contingent basis and has been providing quality individuals to National Fortune 100