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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary
Providing support to the Technical Director to ensure compliance of the Quality Operations, Regulatory and cGMP Compliance Program of Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/FDA Quality Standards, Good Distribution Practices and Internal Quality Standard Operating Procedures) within the organization. The position ensures that the quality systems are in compliance with the rules and regulations of the regulatory agencies (FDA 21 CFR, PIC/S GDP) and that the company policies and procedures are being followed.
Primary Responsibilities
- Manages the customers of the distributed BioPharma products to ensure compliance to Good Distribution Practices. This includes qualification and requalification via risk analysis, desk audit or on-site audit.
- Works alongside Managed Markets to ensure the distributors of the BioPharma products have an established and current quality agreement.
- Tracks the shipping complaints associated with the distribution of BioPharma and HealthCare Solutions product to ensure they are appropriately reported, recorded and resolved on a timely basis.
- Creates and updates procedures to ensure the respective departments associated with the distribution of product are appropriately incorporated under the GUSA Quality System. This includes BioPharma and HealthCare Solutions.
- Serves as the Training Coordinator (GTP and Manual Training) to establish the Training Profiles of new GUSA employees and distribute and manage the training responsibilities that must be processed manually for GUSA personnel.
- Responsible for the review and record keeping of GUSA's Quality Systems records: CAPA, deviation, Complaints, Returns, Inventory Control, review and closure of HealthCare Solutions Hospital Call Center Service Cases.
- Assists Technical Director in ensuring the GUSA's Quality System are compliant to the applicable regulations.
- Works with HealthCare Solutions Customer Service to ensure suppliers/product/materials are reviewed for Regulatory Requirements by Global Marketing and approved by GUSA for distribution within the United States prior to issuing an SAP Code.
- Performs Internal Audits to ensure that the GUSA Quality Systems are compliant to Good Distribution Practices.
- Performs Supplier Audits to ensure that the product being supplied to GUSA for distribution within the United States meets the US Regulatory Requirements.
- Maintains the Approved Supplier List for GUSA.
Additional Responsibilities
- Support overall other Grifols divisions (domestically & globally), to ensure a compliant Quality Management Systems, GDP and etc.
Knowledge, Skills, & Abilities
- Possess certification to a quality professional organization, e.g. ASQ CQA
- Proficient with Good Distribution Practices
- Proficient with FDA Medical Device Requirements (CDRH - Center for Devices and Radiological Health)
- Proficient with FDA requirements for Biologics (CBER - Center for Biologics Evaluation and Research)
- Strong leadership and mentoring skills. Excellent project execution skills with an ability to manage multitask and prioritize in a fast-paced environment.
Requirements
- B.S. in a life science related field.
- 8 years extensive experience working in domestic and global quality operating and manufacturing efforts in a matrix environment within medical device and pharmaceutical "regulated" industries.
- Proven track record of performing and maintaining quality records that comply with regulatory requirements resulting in enhanced safety, profitability, productivity and quality.
- Experience in working with multi-site manufacturing facilities for medical device companies (start-up, mid size and High-volume manufacturing).
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands
- Travel: 15%
- Work is performed in an office and/or a laboratory/manufacturing environment or plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. 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 words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Third Party Agency And Recruiter Notice
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
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