Augustbioservices57mo ago

Product Quality Assurance Manager

United States·NashvilleFull-Timemid

OtherQuality Assurance Manager

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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 Product Quality Assurance Manager is responsible for supporting Quality Assurance Operations at August Bioservices. The PQA Manager dispositions all products manufactured and packaged at the site and manages the team responsible for the AQL / Quality-On-The-Floor Program. Successful candidates will be a team player and have exceptional communication skills, a concern for excellence, ability to develop and mentor a team, and a high ability to collaborate with various levels of the organization.

The Product Quality Manager represents the QA department on internal and external meetings related to the release of batches ensuring quality requirements are met.

Disposition of batches manufactured: at August Bioservices, tracking batch release, and partnering with other departments to close out all required deliverables to support disposition (including but not limited to: executed batch records, deviations, change controls, and environmental monitoring investigations).

Ensures processes are executed according to batch records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified.

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.

Review and approve batch records and labels. Review change controls, deviations, CAPAs, and environmental monitoring investigations related to production.

Communicate lot disposition pending issues to senior management.

Develop, 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.

Manages the quality assurance team responsible for AQL/Quality-On-The-Floor.

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.

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.

Quality lead for client audits and regulatory inspections. Provide support during internal audits.

Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.

Communicate clearly with cross-functional teams.

Master’s Degree and 5+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR Bachelor’s Degree and 7+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR High School Degree and 11+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

Must have proven track record with batch disposition activities.

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, preferred

Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work as well as the work of their team.

Experience in managing a team.

ADA Accommodation Notice

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).
Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.

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.