Sr Quality Systems Specialist

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!

August Bioservices is seeking a Sr. Quality Systems Specialist to join our growing team! Reporting to the Manager, Quality Systems, the Sr. Quality Assurance Specialist is responsible for the administration of the electronic quality management system (eQMS) including improvements and implementations and administration of the training program managed within the eQMS. This role is fully on-site in Nashville, TN.

Responsibilities

• The Sr. Quality Systems Specialist is responsible for the administration and maintenance of the MasterControl system and for providing support of the electronic quality management system and management of the training program
• This position is responsible for system configuration and control of electronic data in MasterControl
• This role serves as the main point of contact for support for all system users
• This position reports to the Manager, Quality Systems
• This position leads project and process improvements for the MasterControl system
• Administer and maintain system configuration and controls
• Build reports and analytics for users
• Escalate issues to MasterControl technical support and communicate regularly
• Manage user accounts for onboarding, offboarding, and staffing updates
• Manage roles for access rights in the system
• Ensure the integrity of data in the system
• Build and maintain electronic forms
• Build and maintain infocards, workflows, vaults, and lifecycles
• Review system audit trails and changes
• Review and assess system performance and trends
• Support the implementation and validation of system changes and upgrades
• Develop training for users of the system
• Provide support during audits and regulatory inspections
• Manage and lead projects from start to completion
• Complete required training on time
• This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors, and file cabinets
• May be required to attend seminars and conferences

Skills and Qualifications

• Bachelors degree in a science, business management, or information management related discipline
• 5+ years of progressive experience in quality systems management or in a highly regulated industry
• Experience with the administration and management of MasterControl Software
• Knowledge of data integrity expectations, GxP compliance, software development lifecycle, and good documentation practices
• Experience in interacting and working with cross functional teams
• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
• Strong technical abilities with an understanding of quality management systems
• Strong understanding of governing regulations and standards for computerized quality systems and data integrity
• Ability to investigate, problem solve issues, and recommend solutions with no supervision
• Ability to work efficiently and effectively under tight deadlines and maintain high quality output
• Skilled in improving processes and removing bottlenecks
• Strong project management skills
• Articulate with excellent verbal and written communication skills
• Capable of presenting complex information in an easy-to-understand format
• Ability to think creatively and strategically; highly driven and self-motivated
• Oriented towards detail, thoroughness, and accuracy
• Ability to follow written instructions and procedures
• Ability to write and review documents and procedures
• Positive attitude with a collaborative mindset
• Ability to take on additional tasks/assignments as needed
• Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer
• Must be able to occasionally lift a maximum of 45lbs

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.