Bionova Scientific ยท 3 weeks ago
QC Sample Admin Specialist
Fremont, CA
Full-time
Onsite
Entry, Mid Level
$85K/yr - $100K/yr
2+ years expBionova Scientific is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products. The QC Sample Admin Specialist will manage laboratory controls, oversee IT systems, and lead continuous improvement efforts in the Quality Control department.
BiopharmaBiotechnology
Responsibilities
Administrate LIMS system, update Master Data for release and stability testing
Take over lead in implementation of new workflows in the LIMS improving lab efficiency and compliance
Be the lead in suggesting IT solutions to support lean and efficient processes within QC and the interface to other departments
Have oversight over sample inventory
Present sample management processes and IT systems in internal/corporate client audits and health authority inspections
Responsible aliquoting and distributing samples for the appropriate QC tests
Key point of contact when working with internal and external partners (MFG, QA, external labs and clients)
QC SME for IT aspects of Data Integrity initiatives
Lead cross-functional investigations or assessments in support of change controls, CAPA/investigations, or other compliance activities as it relates to QC IT systems or sample management activities. Define appropriate corrective actions as necessary
Manage complex projects
Qualification
Required
Bachelor's Degree from an accredited institution in Chemistry, or Biology (or closely related degree)
Strong IT background
Requires 2-5 years of pharmaceutical or medical device experience
Experience with pharmaceutical IT systems (e.g. LIMS, eBR, Enterprise Management Systems (EMS), or Enterprise Resource Planning Systems (ERP))
Strong independent judgment and decision-making abilities and strong conflict resolution required
Knowledge and experience with 21 CFR Part 11 and Annex 11 compliance
Participates in Data Integrity and continuous improvement initiatives
Participates or experience leading projects with history of achieving results
Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little supervision
Ability to make independent sound decisions and manage priorities in alignment with department and site drivers
Benefits
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.
Company
Bionova Scientific
Bionova Scientific is a biologics company presents services for cell line development.
51-200 employees
H1B Sponsorship
Bionova Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Great Point Partners
2022-04-19Acquired
2019-06-03Private Equity
Leadership Team
Darren Head
Chief Executive Officer
Rod Fuhriman, CPA, MBA
Chief Financial Officer
Recent News
Genetic Engineering News
2026-01-11
Company data provided by crunchbase