Job Details

QC Sample Admin Specialist Bionova Scientific

Bionova Scientific LLC is a rapidly growing biologics CDMO focused on creating recombinant protein products using mammalian cell culture processes. Leveraging top scientific talent and an agile culture, we deliver solutions that exceed client expectations.

Position Summary

This role oversees laboratory controls and QC specific IT systems, including LIMS master data administration, user management, workflow design, and document issuance. The position is responsible for independent judgment in resolving quality control sample management issues, leading continuous improvement efforts, and implementing lean IT?supported processes.

Essential Duties and Responsibilities

• Administrate the LIMS system and update master data for release and stability testing.
• Lead implementation of new LIMS workflows to improve lab efficiency and compliance.
• Suggest IT solutions to support lean processes within QC and interfaces to other departments.
• Oversee sample inventory and documentation.
• Present sample management processes and IT systems in audits and inspections.
• Aliquot and distribute samples for QC tests.
• Serve as the key contact for internal and external partners (MFG, QA, external labs and clients).
• Act as QC SME for IT aspects of data integrity initiatives.
• Lead cross?functional investigations or assessments related to QC IT system compliance, including CAPA, change controls, and corrective actions.
• Manage complex projects.

Working Conditions

• Required to work in a laboratory setting.

Qualifications

• Bachelors Degree in Chemistry, Biology, or a closely related field.
• 25 years of pharmaceutical or medical device experience.
• Strong IT background with experience in LIMS, eBR, EMS, ERP, or similar systems.
• Proficiency with 21?CFR Part?11 and Annex?11 compliance.
• Experience with data integrity and continuous improvement initiatives.
• Strong independent judgment, decision?making, and conflict resolution skills.
• Demonstrated initiative and ability to manage priorities with minimal supervision.

Compensation

Base salary range: $85,000 $100,000, depending on experience and qualifications.

Benefits

• Health benefits at a subsidized rate.
• Healthcare, dental, and vision insurance.
• Life insurance and disability program (100?% covered).
• Retirement plan (401(k)) with up to 8?% employer match.
• Paid time off up to two weeks.
• 10 business holidays and 5 sick days.

Equal Opportunity Employer Asahi Kasei believes a diverse workforce will continuously support the changes in the economy, society, and environment.