QA Associate - Temporary and Full Time

Asahi Kasei • Fremont, CA

10d • Hybrid

About The Position

Bionova Scientific LLC is seeking a motivated and experienced QA Associate to join its Quality Assurance department. This is a 4–6 month assignment with the potential for renewal. The role works independently to provide quality assurance oversight for Document Management and Training in the MasterControl Quality Management System (QMS). The position is based in Fremont, California, and requires work primarily in an onsite office setting, with the posting also identifying the role as hybrid.

The QA Associate supports electronic document and record management systems, provides user assistance and training, and helps ensure controlled documents and training processes meet applicable GMP and GxP requirements. The role also responds to user inquiries and collaborates with stakeholders across departments.

Requirements

• Associate’s degree and/or at least 2 years of related experience.
• At least 2 years of pharmaceutical or life-sciences experience.
• Experience with electronic quality systems and Learning Management Systems, specifically MasterControl or equivalent.
• Strong working knowledge of GMP practices and their application to SOPs, work instructions, and controlled records.
• Strong understanding of version and revision control for various controlled document types.
• Proficiency in Microsoft Word formatting, including styles, pagination, section breaks, headers and footers, table properties, attachments, and page layouts.
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
• Excellent communication skills and ability to collaborate with stakeholders across departments.
• Ability to handle multiple tasks concurrently and complete them in a timely manner.
• Strong independent judgment, decision-making, and conflict-resolution abilities.
• Initiative and ability to take on additional responsibilities and respond to situations with little supervision.
• Ability to make sound independent decisions and manage priorities in alignment with department and site needs.

Responsibilities

• Manage electronic quality-system document coordination and control activities, including in MasterControl.
• Provide user assistance, training, and oversight on document control and record management systems, processes, and procedures.
• Perform administrative tasks to maintain the electronic document management system.
• Identify and escalate gaps and discrepancies in controlled documents and related processes, including formatting, SOP style consistency, wording, and change controls.
• Assist users with formatting SOPs, work instructions, and quality agreements using approved templates, and finalize controlled forms.
• Support the GxP training program, including role-based training, curricula hierarchy, instructor-led training, and training assignments.
• Respond promptly to email inquiries and provide user support.
• Manage multiple tasks and priorities and complete work in a timely manner.

What This Job Offers

• Career Level: Mid Level
• Education Level: Associate degree