QA Associate - Temporary and Full Time

Celgard•Fremont, CA

11d•$40 - $45•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 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 is described as hybrid, though the working conditions state that work is primarily in an office setting onsite.

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 an equivalent system.
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.
Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
Ability to make sound independent decisions and manage priorities in alignment with department and site drivers.
Proficient in Microsoft Word formatting, including styles, pagination, section breaks, headers and footers, table properties, attachments, and page layouts.
Strong working knowledge of GMP practices and GxP training program requirements.

Responsibilities

Manage electronic quality systems, including MasterControl document coordination and control activities.
Provide user assistance, training, and oversight for document control and record management systems, processes, and procedures.
Apply GMP practices to SOPs, work instructions, and controlled records.
Perform administrative tasks to maintain the electronic document management system.
Identify and escalate gaps and discrepancies in controlled documents and their governing processes, including document formatting, SOP style consistency, wording, and change controls.
Maintain version and revision control for different types of controlled documents.
Assist users with formatting SOPs, work instructions, and quality agreements using approved templates, and finalize controlled forms.
Support GxP training program requirements, including role-based training, curricula hierarchy, instructor-led training, and training assignments.
Promptly respond to email inquiries and provide user support.
Manage multiple tasks and priorities and complete work in a timely manner.