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. Be cautious of fraudulent communications claiming to be from Asahi Kasei. Incidents have occurred in which individuals impersonating Asahi Kasei recruiters have contacted people on LinkedIn requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of Asahi Kasei. Please also note that we never ask applicants to make any payments in the recruitment process. If you receive any suspicious messages or recruitment outreach that does not meet these criteria, please do not respond, and report the matter directly to LinkedIn. Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reach out to .... Please note we do not accept resumes or applications via email. Don't see an opening that matches your skills? 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