Sr. QA Specialist

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.

Company:
Bionova Scientific LLC



Company Summary:

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, agility and an interest in transformative action are also common attributes among our team.

Position Summary:

The Sr. QA Specialist will execute quality assurance related activities to ensure compliance with end to end operations (manufacturing, supply chain, QC, etc.), as well as monitoring of the Quality System Management health. Working in a fast-paced CDMO environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual's abilities to perform training, batch records review, data review to implement sound Quality System improvements, documentation review, deviation and CAPA management, change control, etc. In addition, the position requires someone with experience working on cross-functional settings. Client facing experience and data integrity remediation experience is a plus.

Position Responsibilities:
Perform as Quality Point of Contact for client Projects with respect to routine operation (e.g. batch record review, deviations, CAPA, change controls, etc.). Apply risk based approach to decisions made to ensure quality and compliance in daily GMP operations. Able to make decisions independently with no supervision.
Be an advocate for quality culture; drive continuous improvement and partner with other functions to ensure Bionova's processes are compliant and inspection ready
Subject matter expert quality processes and on administration activities related to Bionova's EQMS (electronic system to manage the quality system)
Support and execute batch disposition process related tasks
Provide on the floor oversight of activities in manufacturing, QC, Warehouse and review and approve documents regarding Quality Control and Quality System documentation including deviations (such as OOS), CAPAs, and change control.
Support and conduct key quality related training for employees (e.g. deviation investigator training)
Participate in client audits, as well as Health Authority inspections as SME and/or audit/inspection execution roles
Perform other related duties as assigned from time to time based on company needs.
Working Conditions:

This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 40 pounds independently.

Qualifications:

Bachelors' or higher degree in life sciences, engineering or other related field
5 plus years of experience working in a GMP environment with direct work on manufacturing, quality, process development, and/or quality control experience in biotechnology or pharmaceutical industries
Experience on biotechnology is a plus (Drug Substance manufacturing)
Working knowledge of GMP regulations and guidance (21 CFR, ANNEX 1, ICH, etc.)
Effective organization and planning skills
Demonstrated ability to deal with frequent changes, delays, or unexpected events
Strong technical writing skills
Software skills (including Microsoft Office, SharePoint, Visio, Project, Acrobat Pro, and Master Control (a plus)) and demonstrated troubleshooting and problem-solving techniques
Strategic planning, leadership, and the ability to develop and present training materials to large groups
Effective interpersonal and communication skills. Communication to all management levels and all staff is required with all levels of staff, including executives
Strong team player

Compensation Range:

The base compensation range for this role is between $90,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.