About The Role

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.

QA Essential Duties and Responsibilities

Applies GMP/GLP in all areas of responsibility, as appropriate
Demonstrates and promotes the company's vision
Regular attendance and punctuality
Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
Coordinate workflow and perform daily monitoring to meet TAT
Perform and/or assign other duties as requested to ensure the smooth operations of department
Bachelor’s + 2 years of relevant industry experience, or Master's degree in a scientific field such as Pharmacy, Biology or Chemistry 
Pharmaceutical industry experience
Strong knowledge of global regulatory and cGMP requirements, industry best-practices
Experience with manufacturing operations.
Strong technical writing ability
Position is   full-time, Monday-Friday, 8:00 AM - 4:30 PM
Pay range: $26.25 - $30.00
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
LinkedIn: #LI-EB1