Bionova Scientific · 2 months ago
QA Associate
Fremont, CA
Full-time
Onsite
New Grad, Entry Level
$30/hr - $35/hr
0+ years expBionova Scientific is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products. They are seeking a motivated QA Associate to provide quality assurance oversight and ensure compliance with regulatory and industry standards in manufacturing and quality control operations.
BiopharmaBiotechnology
Responsibilities
Technical acumen and management of electronic quality systems (e.g. Master Control document coordination and control activities)
Ensures Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas
Provides guidance to MFG, Facilities and Engineering, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified
Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations
Ensures timely closure of deviations and oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone
Works closely with cross functional team members to determine root cause and potential preventative/corrective actions
Is required to escalate critical issues within area assigned to senior management team based on severity of the issue
Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change throughout the organization
Participates in inspection readiness activities and is involved in inspections by Regulatory Agencies
May perform other duties as assigned
Qualification
Required
Associate's degree and/or 2+ years of related experience
Requires 0-2 years of pharmaceutical or life-sciences experience
Must possess excellent verbal and written communication skills; good interpersonal skills
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
Preferred
Experience with electronic quality systems is a plus (e.g. Master Control, Veeva, etc.)
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