Sr. QA Specialist - Investigations

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 Sr. QA Specialist - Investigations is responsible for supporting Quality Assurance Operations at August Bioservices. The Sr. QA Specialist - Investigations uses knowledge of root cause problem solving to assist all departments in the investigation of deviations, excursions, etc. to improve the production, packaging, and warehousing processes at the Nashville TN site. The Sr. QA Specialist - Investigations also works with departments to implement corrective and preventative actions resulting in the reduction of repeat events. In addition, the Sr. QA Specialist - Investigations hosts client audits and develops audit response reports. Successful candidates will be a team player and have exceptional communication skills, a concern for excellence, and a high ability to collaborate with various levels of the organization.

Responsibilities

• Using root cause analysis techniques, assist departments with their deviations, OOS/OOTs, complaints, etc. to determine root cause and develop effective CAPAs to prevent recurrence of events.
• Host client audits, develops audit response reports, and tracks actions to completion.
• Perform gap assessments and root cause analysis evaluations to determine RISK level utilizing root cause analysis tools such as FMEA, Fishbone and/or 5 Why tools.
• Using deductive reasoning, interviewing skills, and technical knowledge to assist finding causes of events and circumstances impacting production.
• Identify and resolve objectionable GMP issues which may impact product quality and escalate the issues to management in a timely manner.
• Represent facts or theoretical hypotheses thoroughly and in a clear and concise manner that will withstand scrutiny during inspections by regulatory agencies, customers and vendors.
• The principal investigator will review the production, testing, handling, storage and handling of products & materials through investigation processes to assure products conform to established requirements and standards.
• Lead cross-functional teams to develop and track CAPA plans, host deviation review board.
• Work with operations personnel in determining effectiveness of CAPAs.
• Evaluate and report on trends for investigations, complaints, and CAPAs to identify major areas of opportunity for improvement.
• Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.
• Support during client audits and regulatory inspections.
• Lead and communicate clearly with cross-functional teams.

Requirements

• Bachelor of Science in a Biology/ Quality / Process related or Engineering field, or equivalent skills or experience.
• Six to ten years proven track record of root cause analysis experience in a manufacturing, packaging, engineering, and distribution environment, preferably pharmaceutical / FDA regulated operation.
• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
• Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems, required
• Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work.

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.