Quality Assurance Operations Lead

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!

The Quality Assurance Operations team is responsible for supporting Quality Assurance at August Bioservices. This position is the lead for QA AQL Visual Inspection and on the floor quality. It is new to August Bioservices and will develop the program to ensure Quality Compliance oversight with cGMP, regulatory, and internal requirements regarding the manufacture, testing, and distribution of products through real-time, continuous on-the-floor presence.

This role will interact with all levels of the company in a fast paced and growing environment.

• Implement, coordinate, administer, and continuously improve the Quality Assurance AQL Visual Inspection / On-The-Floor program
• Responsible for development and quality oversight of the visual inspection /quality on the floor program
• Partner with manufacturing and other internal groups to establish a philosophy for visual inspection and develop the visual inspection qualification for operators and QA AQL Specialists
• Build and maintain qualification kits
• Collaborate with manufacturing to develop the program for classification of rejects and AQL levels
• Participate in equipment design and start-up of automated equipment and manual/semi-manual visual inspection start up
• Support implementation / qualification of automated inspection procedures
• Review all SOPs, policies, work instructions, batch records, etc. regarding visual inspection, defects, rejects, and defect kits
• Develop QA documents for visual inspection AQL inspection
• Quality reviewer/approver for visual inspection deviations, change controls, CAPAs, etc.
• Complete training and maintain required qualifications for visual inspections
• Perform QA line clearance for visual inspection and audits of the fill/finish area
• Analyze and trend AQL defects, provide metrics, and present KPIs
• Review and approve process generated data from manufacturing visual inspection
• Ensure regular presence in operational areas and support personnel on quality matters
• Real-time batch record reviews and in-process auditing
• Routine walk-throughs of production areas, laboratories, and warehouse to ensure inspection readiness of the facility, routinely communicate findings and ensure issues are corrected in a timely manner
• Ensure processes are executed according to batch records and procedures; ensure any potential compliance issues identified during batch record review are corrected and clarified
• Provide constructive feedback to individuals executing batch records and communicate best practices to share with different areas of manufacturing
• Collaborate with planning groups to prioritize critical lot disposition, also ensure that the schedule is being monitored and operations has all the required releases to ensure no downtime
• Identify process improvements of batch record review and product disposition processes
• Oversee labeling activities, verify labeling issued to and returned from operations
• Immediately elevate issues to QA management, submit event notifications where appropriate
• Assess and triage deviations that occur with the local process team, write, review, and assess deviations, and participate in investigations; support CAPAs, gap analysis, and product complaints
• Develop strategy on how to achieve the work that needs to…