Quality Assurance Document Controller

Asahi Kasei • The Woodlands, TX

1d • Onsite

About The Position

The Asahi Kasei Group operates with a commitment of creating for tomorrow, contributing to society through its Material, Homes, and Health Care sectors. Bionova, a subsidiary of Asahi Kasei Medical since May 2022, is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Bionova seeks candidates with scientific talent, adaptability, and a desire to serve clients. This acquisition has significantly accelerated Bionova's growth in service offerings and capacity. The Quality Assurance Document Controller will organize, control, and maintain documents within the company’s Document Management System, working independently to provide QA oversight for Document Management, Training, and System Administration functions in the MasterControl Quality Management System. Candidates should demonstrate a compliance mindset, strong communication skills, computer proficiency, and flexibility in work scheduling.

Requirements

• Associate’s degree and/or 2+ years of related experience.
• Requires 3-5 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.
• Strong independent judgment and decision-making abilities and strong conflict resolution are 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.

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 the electronic document management system.
• Identify and escalate 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.
• Responsible for providing reports to Upper Management regarding document status.
• Responsible for maintaining databases used for tracking various GMP documentation.
• Responsible for supporting client audits and regulatory inspections.
• Responsible for processing, distributing, and maintaining controlled documentation (i.e., paper-based Batch Records, SOPs, material specifications, logbooks, etc.) using a document control system

Benefits

• 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: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees