Technical Source is currently in search of a Quality Assurance Specialist for our client located in the Raleigh-Durham, NC area. The qualified candidate will have experience investigating and resolving quality issues, ensuring that products, services, and processes meet industry standards and customer expectations. Their role involves minimizing defects, maintaining regulatory compliance, and promoting continuous improvement.
Responsibilities:
• Responsible for investigation and solution of quality problems on shift
• Non-conformities, Unscheduled Events
• Ensure BPR accurateness and timely approval
• Work with process team to find preventive actions to eliminate re-occurrence of quality problems
• Perform periodic assessment of compliance (audit readiness) of shift personnel
Bachelor's Degree or equivalent industry experience a plus.
• Five (5) years of manufacturing experience in a pharmaceutical environment a plus.
• Two (2) years of Aseptic Processing experience (Aseptic Processing Department only) preferred.
• Knowledge of US, EU regulations and guidelines, and application of GMP’s preferred.
