Quality Assurance Operations Lead - 3rd Shift

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, Quality Assurance is responsible for supporting Quality Assurance Operations at August Bioservices.  This position is the lead for QA AQL Visual Inspection and on the floor quality.  This position is new to August Bioservices and will be responsible for developing 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.

Responsibilities

• 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. 
• Partners with manufacturing and other internal groups to establish a philosophy for visual inspection and develops the visual inspection qualification for operators and QA AQL Specialists.
• Builds and maintains qualification kits.
• Collaborates with manufacturing to develop the program for classification of rejects and AQL levels.
• Participates in equipment design and start-up of automated equipment and manual/semi-manual visual inspection start up.
• Supports implementation / qualification of automated inspection procedures.
• Reviews all SOPs, policies, work instructions, batch records, etc. regarding visual inspection, defects, rejects, and defect kits.
• Develops QA documents for visual inspection AQL inspection.
• Quality reviewer/approver for visual inspection deviations, change controls, CAPAs, etc.
• Completes training and maintains required qualifications for visual inspections.
• Responsible for performing QA line clearance for visual inspection and audits of the fill/finish area.
• Analyzes and trends AQL defects, provides metrics, and presents KPIs.
• Reviews and approves 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.
• Ensures processes are executed according to batch records and procedures.  Ensures any potential compliance issues identified during batch record review are corrected and clarified. 
• Provides constructive feedback to individuals executing batch records and communicates best practices to share with different areas of manufacturing.
• Collaborates with planning groups to prioritize critical lot disposition.  Also ensures that the schedule is being monitored and operations has all the required releases to ensure no downtime.
• Identifies process improvements of batch record review and product disposition processes. 
• Oversees labeling activities, verifies labeling issued to and returned from operations. 
• Immediately escalates issues to QA management, submits event notifications where appropriate.
• Ability to 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. 
• Develops strategy on how to achieve the work that needs to be completed, works with manufacturing to determine schedule and support.    Ensures appropriate coverage which may include some evenings. 
• Provide support during internal / external / regulatory inspections.
• Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.
• Communicate clearly with cross-functional teams.
• Train and quali