Posted 2 years ago in Biotech/Pharmaceutical
The Fountain Group has an IMMEDIATE opening for a QA Compliance Specialist with its direct Fortune 500 client in Holly Springs, NC. Qualified applicants should submit an updated resume along with contact information to be considered
· Supports the implementation of necessary Pharma V&D Quality processes, systems, and procedures regarding self-inspection management
· Ensures preparation, update and implementation of relevant SOPs.
· Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters is provided to the site.
· Reports monthly KPI/KQI's for self-inspections.
· Minimum 5 years relevant experience within biotechnology/pharma/vaccine industry.
· Strong knowledge of EU, FDA and cGMP regulations.
· Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations required.
· Self-Inspection/internal auditing experience required. Certified Quality Auditor (CQA) designation is an asset.
· Excellent interpersonal effectiveness and written and verbal communication skills
· BS in Life Science discipline
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
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