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Quality Manager

Ashland Specialty Ingredients, GP
Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?
Are you always solving?
Then we'd like to meet you and bet you'd like to meet us.
Ashland has an exciting opportunity for a Quality Manager to join our Ashland Specialty Ingredients business at our Freetown, MA location. This is a very visible, significant role within the Company and the Quality Assurance function. This position will report to Quality Systems Manager.
The responsibilities of the position include, but are not limited to, the following:
Support the management, maintenance and continual improvement of the Advanced Material quality management system while safeguarding alignment with applicable FDA standards (21 CFR 820, ISO - 13485), ASI objectives and customer needs.
Implement production, quality, and customer-service standards.
Align and maintain the advanced material QMS with the corporate QMS.
Lead the audit program.
Support supplier management including, maintaining the contract manufacturing evaluation program.
Provide direct customer support responding to customer requests and complaints.
Oversee validation of quality processes through establishment of product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
Developing quality assurance plans by identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and inventories.
Consolidate quality KPIs, prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Provide valuable problem solving, project and change management abilities to lead or participate in continuous improvements in quality.
In order to be qualified for this role, you must possess the following:
B.S. Degree in Chemistry or Chemical Engineering or a related discipline.
A minimum of 3-5 years of experience within the Quality/technical/regulatory function in a medical device or pharmaceutical manufacturing facility.
Manufacturing operations and laboratory experience preferred.
Ideally, experience with cGMP internal and external quality auditing.
Experience working within and complying with FDA, EMEA medical device regulations and ISO 9001:2008 certification programs.
The following skill sets are preferred by the business unit:
Project Management Abilities ? Able to provide problem solving and project management abilities to lead or participate in continuous improvements in product quality, cGMP compliance and the Quality Management System.
Communication Skills ? Able to clearly and effectively communicate verbal and written information appropriately to the audience. Able to deliver information in a formalized and group setting. Able to translate complicated and/or technical information in a simplified format that can be easily understood.
Computer Skills ? Good knowledge of Office tools (Microsoft Office Word, Excel, and PowerPoint). Ability to interpret and analyze statistical data, information and financial reports.
In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.
At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.
Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.
Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.
Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.

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