Supervisor, Product Release

Clayton, NC

Employer:	Grifols Plasma (Biomay USA)
Category:	QA - Quality Control
Job Type:	Full Time
Description
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. Provides supervision of the Product Release Specialist(s) and supports the Plasma Logistics Centers (PLC) by providing expertise to the Quality group, to support activities for both Plasma Logistic Centers (East and West). Provides assistance to both the donor centers and PLCs when completing Shipped Unit Error and Post Donation Information records as it pertains to the removal of unsuitable units and completing consignee notifications. Primary responsibilities for role : Management of the team, such as escalations, ensuring the execution of daily work, maintaining schedule, performance reviews etc. Support activities needed to assess facility compliance with SOPs, applicable domestic regulatory agencies such as FDA, international regulatory agencies such as EMA, federal and state regulations. Supports the Plasma Quality Assurance Manager with coordinating and conducting the Internal Audits at the PLCs. Facilitate Deviation Management by working directly with the PLC Quality Teams on investigations, completes notifications to donor centers when appropriate and assists with updates to Trackwise for deviations. Participates in supporting preparation, conducting, and follow up commitments for internal audits and Regulatory Inspections (FDA, EMA, etc.) Assist the Quality Management teams (including both PLCs and Donor Center Field Leadership) with review of current inventory status and determination of plasma suitability Works directly with Regulatory Affairs to obtain necessary documentation to release plasma for further manufacturing. This includes maintaining the GPOPQD Trackwise system used by both PLCs and the three Grifols manufacturing sites. Works with Director, Product Release to make required updates to the Plasma Management System (SGP) when changes requests are completed for donor centers (new/revised donor center profiles, new material codes, plasma group changes, etc.) Support projects identified by the department or the Organization Supports daily activities associated with identification of plasma inventory to include but not limited to reclassification of plasma, blocking and unblocking plasma, Lookback and Post Donation Information research Assists in development of new or revised procedures based on trends, audit findings, interaction with facilities. Responsible for various aspects of the CAPA system, maintains and develops metrics and coordinates with the Plasma Quality Assurance Managers and the Director, Product Release. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. EDUCATION Bachelor's degree in Allied Sciences (Chemistry, Biology, Med Tech) required. Master's degree in Public Health, Allied Sciences or Business preferred. EXPERIENCE Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals and qualified as a Designated Trainer. Project or technical leadership experience required. Supervisory or management experience preferred. 3 to 5 years of job-related experience. Experience with project management on multiple projects simultaneously. Previous experience should demonstrate expertise in cGMPs, FDA regulations, SOP implementation and an understanding of quality control principles. KNOWLEDGE, SKILLS & ABILITIES Ability to highlight areas for improvement to process/product. Must be detail oriented. Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills required. Ability to manage staff not directly reporting to the position. Must be able to multi-task and work independently with little direct oversight on a day-to-day basis while producing expected results. Ability to produce effective presentations and execute the messages to multiple levels of staff within GPO Operations in order to gain consensus or approval. Ability to travel up to 25% of the time. Expertise with Microsoft Office suite required, Trackwise (preferred), SGP and NexLynk (preferred). 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. #biomatusa 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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws. Learn more about Grifols (https://www.grifols.com/en/what-we-do) Req ID: 524988 Type: Regular Full-Time Job Category: Quality

Back

Supervisor, Product Release

Clayton, NC

Description