QC Analyst I
Bionova Scientific LLC

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

Job Description:

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

Position Summary:

Bionova is seeking a motivated and innovative QC analyst in the Environmental Monitoring and Sample management department to contribute to our expanding business.

This position will provide critical data to assure all GMP activities performed in the controlled area are within set guidelines. Additionally, this position will have the opportunity to provide our business with critical observations of the site to help improve the facility as we expand.

Essential Duties and Responsibilities:

• Conduct Environmental Monitoring (EM) of ISO 5, 7, and 8 (Grade B, C, D) cleanrooms for Non-viable, Air Viable, and Surface Viable.
• Gas sampling of Oxygen, Clean Compress Air (CCA), and CO2.
• Perform WFI sampling within and outside of the cleanroom.
• Off-testing of EM/In-Process samples.
• Perform Gowning Qualifications on personnel.
• Perform sample management activities such aliquot samples to laboratory.
• Receive and track samples for completion.
• Create LIMS labels.
• Track and Trend EM data including Microbial identification.
• Submitting samples for Microbial Identification.
• Monitor incubator and refrigerator temperature.
• Assist in laboratory investigations for EM excursions.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
• Write/Revise EM SOPs
• Assist with the implementation of enhancements of new processes.
• Troubleshoot equipment and testing to identify root causes of issues.
• Maintain equipment calibrations per established procedures.
• Maintain media and supplies inventory.
• Perform Laboratory Maintenance such as daily cleaning.
• Contribute to investigation of issues and non-conformities related to EM.
• May perform other duties as assigned.

Working Conditions:

• This position requires you to work in a lab setting and cleanroom environments that 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 25 lbs.

Qualifications:

• Associate's degree and/or 1+ year of related experience
• Requires 0-2 years of pharmaceutical or medical device experience.
• Experience in microbiology testing a plus.
• Aseptic technique experiences preferred.
• Gowning experience preferred.
• 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 respond to situations as they arise with little supervision.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint.
• Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.

Compensation Range: The base compensation range for this role is between $25 to 30 an hour. 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.

---