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Quality Assurance Supervisor (New Center)

Company: Octapharma Plasma
Location: Oakland
Posted on: December 9, 2018

Job Description:

Want to be a part of something exciting? Help Octapharma Plasma open our next Donor Center! At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding. We own and operate plasma collection centers throughout the United States. Our services are critical to the development of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world's largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patient care and medical innovation for over 30 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide.Quality - Regulatory - OperationsJob ResponsibilitiesWe are seeking a Quality Assurance Supervisor to join our growing biopharmaceutical company and assist in opening our newest Donor Center. Reporting into the Regional Director of Operations, this position is responsible for the overall quality program of the Donor Center. You will provide advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality. Additional responsibilities of the Quality Assurance Supervisor role include:. Determines if quality activities and manufacturing records are in compliance with SOPs and regulatory requirements; determines the need for corrective actions; ensures proper documentation and determines effectiveness of the action . Performs final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications . Performs regular quality compliance audits of the center activities, i.e., manufacturing records, donor processing, plasma collection, product sampling, processing storage and shipping . Provides direction and oversight of Quality staff ensuring required quality tasks are completed within required time frames . Identifies desired career path goals of the Quality staff and provides coaching and mentoring to aid the Quality staff in achievement of career goals . Prepares staff and co-hosts both internal and external audits . Collaborates with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames . Ensures that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff . Obtains certification as a Quality Trainer; responsible for training of center Quality Assurance staff . Analyzes tracking and trending data; determines appropriate actions to improve trendingQuality - Regulatory - OperationsJob RequirementsQualified candidates of this role must offer a Bachelor's degree in an applicable field of study (or an equivalent combination of education and experience may be considered). An ASQ certification is preferred. You must offer strong organizational skills, attention to detail and excellent interpersonal skills. Other requirements of the Quality Assurance Supervisor role include:. Must have a minimum of one (1) year work experience in the biologics industry, preferably in a donor center, and a minimum of one (1) year quality assurance-related work experience . Supervisory experience preferred . Must possess knowledge and aptitude to learn various computer software; such as word processing, spreadsheets or other related software programs . Must have adequate communication skills and be able to effectively communicate with people at all levels . Must have ability to make decisions impacting the product and donor safety based on independent judgment and discretionQuality - Regulatory - OperationsBenefitsAt Octapharma Plasma we believe in our employees who have the passion and ability to make a difference to the quality of life of their communities. The individual growth and success of each and every employee at Octapharma Plasma is an integral part of our continued growth and success. We offer competitive compensation and a comprehensive benefits package.Other benefits include:. Medical, Dental and Vision Insurance. Life Insurance. 401(k) contribution and matching program. Flexible Spending Accounts. Tuition Reimbursement. Team-oriented environment. Recognition programs Associated topics: automation, performance test, prevent, prevention, qa, quality assurance, quality assurance analyst, software quality, software quality assurance engineer, test

Keywords: Octapharma Plasma, Oakland , Quality Assurance Supervisor (New Center), Other , Oakland, California

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