Quality Assurance Document Controller

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Bionova Scientific LLC

Job Description:

Position Summary

The Quality Assurance Document Controller will organize, control, and maintain Documents within the company’s Document Management System. All candidates will be able to demonstrate a compliance mindset, proficiency in communication (written and verbal), competence with computers and business software, and be timeline focused and flexible in their work scheduling. This position will work independently to provide quality assurance oversight pertaining to Document Management Administration, Training Administration, and System Administration functions in the MasterControl Quality Management System.

Essential Duties and 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

Working Conditions:

• This position requires you to work primarily in an office setting onsite based in The Woodlands, Texas.

Qualifications:

• 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.

Health Benefits and Program: Bionova offers 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

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.