QA Associate - Document Control & Training (Hybrid)

Bionova Scientific, Inc.; Fremont (CA); On-site; USD 55,000 - 62,000; Full time

Job summary

Bionova is seeking a motivated and experienced QA Associate to join the Quality Assurance department. This is a 4-6 month assignment with a potential renewal. This position will work independently to provide quality assurance oversight pertaining to Document Management and Training in the Master Control Quality Management System (QMS).

Location: Fremont, California. This role requires you to work primarily onsite in Fremont, CA with hybrid options indicated.

Qualifications

• Associate’s degree and/or 2+ years of related experience.
• At least 2 years of pharmaceutical or life-sciences experience.
• Experience with electronic quality systems and MasterControl or equivalent.
• Excellent communication skills with the ability to collaborate with a wide range of stakeholders in various departments.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.

Responsibilities

• Technical acumen and management of electronic quality systems (e.g. Master Control document coordination and control activities).
• Provide user assistance, training, and oversight on document control and record management systems, processes, and procedures.
• Strong working knowledge of GMP practices and how they might apply to SOPs, work instructions, and controlled records.
• Perform administrative tasks to maintain both the electronic document management system.
• Identify and escape gaps and discrepancies in controlled documents and the processes that govern them (e.g. document formatting, SOP style consistency, clear and concise wording, document change controls, etc.).
• Strong understanding of version and revision control for a variety of controlled document types.
• Assist users with formatting documents such as SOPs, work instructions, or quality agreements using approved templates and finalizing controlled forms.
• Proficient in Microsoft Word formatting including styles, pagination, section breaks, headers and footers, table properties, attachments, and page layouts.
• Strong grasp of GxP training program requirements, including role-based training, curricula hierarchy, instructor led training, and training assignments.
• Ability to promptly respond to email inquiries and user support.

Skills

Document control

Quality systems

Communication

Training

Education

Associate degree

Tools

MasterControl

Microsoft Word

LMS

Job description

Bionova is seeking a motivated and experienced QA Associate to join the Quality Assurance department. This is a 4-6 month assignment with a potential renewal. This position will work independently to provide quality assurance oversight pertaining to Document Management and Training in the Master Control Quality Management System (QMS).

Location: Fremont, California. This role requires you to work primarily onsite in Fremont, CA with hybrid options indicated.