Supplier Quality Specialist
Nashville, Tennessee
Quality – Quality Assurance /
Full-Time /
On-site
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
Supplier Quality Specialist is responsible for supporting the development, management, and execution of the supplier quality program to ensure compliance with the requirements of regulatory authorities, cGMP and customers. This role is responsible for supplier quality management for providers of raw materials and services, ensuring suppliers are capable of meeting quality standards and support of the quality systems documentation control. This role must have the ability to drive continuous improvement of the supplier quality management program in a fast paced and growing environment.
Responsibilities
- Execute Implement, coordinate, administer, and continuously improve the Supplier Quality Assurance Program, including the following
- Plan and execute supplier audits, via desktop and on-site assessments, for new suppliers and on-going approvals.
- Maintain approved vendor list within electronic quality management system.
- Continuously assess supplier status through periodic monitoring and reporting. Report supplier quality performance metrics to senior management and business partners quarterly.
- Prepare quality agreements and support execution including coordination of negotiations with suppliers, customers and or partners, documentation of those quality agreements, and tracking adherence to quality agreement requirements.
- Lead the supplier change notification process and ensure notifications are assessed for impact based on risk.
- Identify and mitigate risk at the supplier and/or escalate to management.
- Support quality systems documentation control within MasterControl.
- Support physical documentation control initiatives.
- Support client audits
- Communicate clearly with cross-functional teams and customers.
- Ensure GxP compliance of all August products and services.
- Ensure customer expectations are met or exceeded.
Requirements
- Bachelor’s degree in science or other related discipline
- A minimum of 3 years supplier quality management experience in the pharmaceutical industry
- Experience performing quality system audits of suppliers
- Ability to write reports effectively and concisely
- Experience interacting with customers, suppliers, and senior management
- Knowledge of cGMPs and other global regulations and guidelines related to the manufacture of APIs and drug products
- Experience with electronic Quality Management Systems is desired
- Experience with Pharmaceutical Development and Clinical Trials is desired
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
