QA Associate

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve.

Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Bionova Scientific LLC

Bionova is seeking a motivated and innovative QA Associate to join the Quality Assurance department to contribute to our expanding business.

This position will work independently to provide quality assurance oversight activities of any assigned operations department to ensure adherence to cGMP’s, regulatory, industry, and Bionova requirements including manufacturing, batch record review, batch disposition, new product introduction/product transfer, external quality and quality control, critical utilities, (e.g., WFI, Steam, Automation, equipment, HVAC, etc.) and warehouse.

• Technical acumen and management of electronic quality systems (e.g. Master Control document coordination and control activities).
• Ensures Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
• Provides guidance to MFG, Facilities and Engineering, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
• Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations.
• Ensures timely closure of deviations and oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
• Works closely with cross functional team members to determine root cause and potential preventative/corrective actions.
• Is required to escalate critical issues within area assigned to senior management team based on severity of the issue.
• Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change throughout the organization.
• Participates in inspection readiness activities and is involved in inspections by Regulatory Agencies.
• May perform other duties as assigned.

• This position requires you to work primarily in an office setting, while also supporting oversight activities in Manufacturing, QC and the Warehouse. (cleanroom environments such manufacturing require appropriate gowning).
• Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
• Must be able to lift, push, and carry up to 10 lbs.

• Associate’s degree and/or 2+ years of related experience.
• Requires 0-2 years of pharmaceutical or life-sciences experience.
• Experience with electronic quality systems is a plus (e.g. Master Control, Veeva, etc.).
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Strong independent judgment and decision-making abilities and strong conflict resolution required.
• Demonstrates initiative; ability to undertake additional responsibilities and…