QA Associate: GMP & Document Control (Hybrid CA)

AK America; Fremont (CA); Hybrid; USD 55,000 - 62,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a motivated QA Associate to join the Quality Assurance department for a 4-6 month assignment with potential renewal. The role focuses on electronic quality systems, document control, and GMP compliance.

You will train users, manage records, and support formatting and control of SOPs and forms, working onsite in Fremont with hybrid flexibility. Strong communication and independent judgment are essential.

Qualifications

• Associate's degree and/or 2+ years of related experience.
• Requires at least 2 years of pharmaceutical or life-sciences experience.
• Experience with electronic quality systems and Learning Management Systems, specifically MasterControl or equivalent.
• Excellent communication skills with the ability to collaborate with a wide range of stakeholders in various departments.
• 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 andescalate 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

GMP practices

Training

Communication

MS Word formatting

Education

Associate degree

2+ years related experience

Tools

MasterControl

Job description

Bionova Scientific LLC in Fremont, CA is seeking a motivated QA Associate to join the Quality Assurance department for a 4-6 month assignment with potential renewal. The role focuses on electronic quality systems, document control, and GMP compliance.

You will train users, manage records, and support formatting and control of SOPs and forms, working onsite in Fremont with hybrid flexibility. Strong communication and independent judgment are essential.