AQL 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!

The AQL Specialist, Quality Assurance is responsible for supporting Quality Assurance Operations at August Bioservices.  This position is new to August Bioservices and will be responsible for executing 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

• Team member in the Quality Assurance On-The-Floor group:
• Designated Observer, responsible for On-The-Floor activities related to controlled substance surveillance from loading dock through production.
• Performs AQL visual inspection. 
• Supports implementation / qualification of automated inspection procedures.
• Completes training and maintains required qualifications for visual inspections.
• Performs QA line clearance for visual inspection and audits of the fill/finish area.
• Ensure regular presence in operational areas and support personnel on quality matters.
• 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.
• 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. 
• 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.

Requirements

• Bachelor’s or Associates degree in science or other related discipline, or equivalent level of skill and experience
• A minimum of 1 years of AQL inspection experience in the pharmaceutical industry with liquid and lyophilized products
• Highly organized individual with strong attention to detail
• Ability to management time and priorities effectively

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.