Results-driven Quality Assurance Specialist with expertise in cGMP guidelines from Quva Pharma. Proven track record in conducting thorough inspections and enhancing quality management systems. Strong communicator and team builder, adept at mentoring future leaders and driving process improvements to ensure compliance and operational excellence.
Quality Assurance professional with strong background in ensuring product integrity and compliance. Skilled in identifying system inefficiencies, implementing effective quality control measures, and enhancing operational processes. Known for fostering team collaboration and adapting to evolving project demands while consistently achieving high-quality results. Equipped with analytical skills, attention to detail, and commitment to continuous improvement.
● Conduct routine inspections and quality checks of incoming materials, ensuring compliance with company, FDA & DEA standards/ regulatory guidelines.
● Verify and document inspection results to maintain accurate quality control records.
● Perform audits of pharmaceutical materials, labels, sterile supplies, and physical/electronic batch record reviews.
● Identify and escalate discrepancies with internal teams to resolve quality issues.
● Calibrate equipment for vial testing and API Sampling.
● Sample incoming Active Pharmaceutical Ingredients for lab testing, disposition, and logging of Active Pharmaceutical Ingredients.
Certified CII Active Pharmaceutical Ingredients and sampling in clean room environments
• Received and sorted inventory to meet customer needs
• Utilized computers and handheld devices to process customer orders, record and monitor inventory levels, and complete audits to uncover and address inaccuracies.
● Supervised all warehousing and distribution functions for a location handling 25K units per day. Managed 70+ employees and initiated measures to strictly adhere to legislative, safety, and organizational policies and procedures.
● Encouraged high expectations and a collaborative work environment, setting team
priorities and performance objectives, reviewing performance and methods employed, and spearheading the team's decision-making process.
● Nurtured future leaders in the organization and maintained a culture of excellence in mentoring and developing three new supervisors
● Set the standard for maximizing staff productivity by devising an operating plan with clearly defined performance standards, metrics, and workflows tracked against timelines and used to evaluate the performance.
● Knowledgeable in cGMP guidelines and quality management systems
● Proficient in conducting routine inspections & equipment testing
● Quickly learn new skills and procedures with excellent memory retention ● Experienced in accurately documenting sample results for perpetual logs ● Strong computer and communication skills
● Team Building and Development
● Process Improvement