QA Associate

Asahi Kasei • Fremont, CA

52d • $30 - $35

About The Position

Bionova is seeking a motivated and innovative QA Associate to join the Quality Assurance department to contribute to our expanding business. This position will work independently to provide quality assurance oversight activities of any assigned operations department to ensure adherence to cGMP’s, regulatory, industry, and Bionova requirements including manufacturing, batch record review, batch disposition, new product introduction/product transfer, external quality and quality control, critical utilities, (e.g., WFI, Steam, Automation, equipment, HVAC, etc.) and warehouse.

Requirements

• 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.

Nice To Haves

• Experience with electronic quality systems is a plus (e.g. Master Control, Veeva, etc.).

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees