Biomat USA, Inc. Supplier Quality Specialist in Raleigh, North Carolina
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
This position will be office based in RTP with a Hybrid work schedule
Responsible for performing aspects of the Supplier Quality function on an on-going basis in line with the Quality Management System and Quality Policy to ensure that the business’ products and services are fit for purpose and meet customer expectations. Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems through the active participation in the supplier quality team.
Active participation in and execution of the Biomat USA supplier quality program.
Involvement in Biomat USA supplier quality program, specifically; manage new and ongoing qualifications of suppliers and supplies, manage supplier corrective action requests (SCAR) and nonconformance evaluations (NCE).
Assess defective supply trending data and propose appropriate actions internally and with suppliers to ensure a consistent supply of necessary items in a compliant manner.
Involvement and participation of any necessary quality audits, technical visits, questionnaires in order to complete and/or maintain active suppliers.
Actively manage the Biomat USA Approved Supplier List, including addition or disqualification or suppliers, or removal of duplicate suppliers (in conjunction with purchasing and regulatory teams).
Assist in the completion or amendment of necessary Supplier Quality Agreements and interact with regulatory, legal and purchasing teams (and others) on these quality and business/service agreements.
Stay current and up to date on any changes that may affect the supply and demand of needed products and materials and advise others of any impact.
Monitors supplier quality related activities and reports issues to management.
Write/revise Change Requests, SOPs or other documents as needed
Utilize the various supplier quality tools to complete tasks.
Performs additional tasks, when needed (e.g. Side projects, additional inspections, etc.)
EDUCATION & EXPERIENCE
BS degree is required, with a preference for an MS degree in a life science field.
Typically requires a minimum of 3 years of related experience. Supervisory experience preferred but not required.
Strong knowledge of current Good Manufacturing Practices (cGMPs), supplier quality standard operating procedures and supplier quality principles and quality management systems. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications
Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32
and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols
Req ID: 418807
Type: Indefinido tiempo completo
Job Category: Calidad