QC Specialist - EM and Micro Testing

QC Specialist - EM and Micro Testing

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

Position Summary

The QC Lab at Bionova is seeking a self‑motivated, innovative, and team‑oriented QC Analyst with strong technical and communication skills to support microbiology testing of biologics. In this role, you will contribute to a dynamic and expanding business as part of a rapidly growing Quality Control team. You will have the opportunity to influence decisions, collaborate cross‑functionally, and develop your own skills while working toward project goals that ultimately improve patient outcomes.

Essential Duties and Responsibilities

• Perform microbiology testing for routine EM, release, stability, and method verification samples.
• Read plates from environmental monitoring and media fill.
• Perform growth promotion and Gram staining.
• Perform endotoxin, TOC, and bioburden testing.
• Enter data in electronic systems and LIMS.
• Manage and order supplies as needed for testing.
• Assist in QC team implementation of GMP procedures, processes, and systems.
• Train QC staff on instrumentation, techniques, microbiology methods.
• Initiate trend reports.
• Author/review/approve technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents per project needs.
• Initiate/investigate deviations, change control and CAPA.
• Maintain lab equipment as per procedures.
• Contribute to investigation of issues and non‑conformities to products and projects and troubleshoot equipment and testing procedures to identify root causes and participate in lab investigations.
• Help maintain the QC lab clean, organized, and compliant at all times.
• Perform other QC tasks as required.

Working Conditions

• This position is required to work in a lab setting.
• Must be able to lift, push, and carry up to 25 lbs.

Qualifications

• Bachelor's Degree or above in Microbiology, Biology, or a closely related field.
• 4+ years of quality pharmaceutical, bio‑pharmaceutical, or combinational medical device experience, and analytical testing experience on Biologics.
• Energetic scientist and creative thinker who explores and identifies better and more efficient methods to address issues and gaps.
• Ability to work independently and on cross‑functional teams.
• Strong attention to detail and following procedures and requirements.
• Effective verbal and written communication skills.
• Great interpersonal and teamwork skills.
• At least 2 years of technical writing experience such as SOP, CAPA, deviation reports, etc.

Compensation Range

The base compensation range for this role is between $80,000 and $100,000, although the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program

• Health, dental, and vision insurance (subsidized).
• Life insurance and disability program: 100% covered by Bionova.
• Retirement plan (401K) up to 8% employer match.
• Paid time off up to two weeks.
• 10 days of holidays and 5 days of sick leave.

Equal Opportunity Employment

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.