Pharmaceutical Compliance Specialist

Responsibilities

• Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
• Collaborating with cross functional client Quality and other PSS site team.
• Collecting data from various process areas, defect reports and performance metrics.
• Analyze the data to identify trends, patterns, and areas of improvement.
• Generate regular investigation, training reports to provide visibility into quality performance.
• Manage quality improvement activities, meetings and other activities supporting the work of the departments.
• Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization.
• Present findings in meetings, reviews, and reports to facilitate informed decision making.
• Evaluate and managing resources and task- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.
• Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
• Assist with other aspects of quality improvement including administrative and operational support as needed.
• Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements.
• To ensure adherence with quality standards and best practices.
• Evaluate the thoroughness and effectiveness of the training program.
• Foster a culture of quality awareness and continues improvement throughout the organization.
• Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.

Qualifications

Bachelor’s + 2 years of relevant industry experience, or Master's degree in a scientific field such as Pharmacy, Biology or Chemistry +1 year of relevant experience.Relevant experience may include:Quality investigations, deviations, audits, CAPAs, quality management systems, controlled document storage, etc. Pharmaceutical industry experienceStrong knowledge of global regulatory and cGMP requirements, industry best-practicesExperience with manufacturing operations.Strong technical writing ability

Benefits

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Pay

Pay range: $26.25 - $30.00

Schedule

Position is full-time, Monday-Friday, 8:00 AM - 4:30 PM