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Validation Analyst

2 months ago

Charleston, United States Haemonetics Full time

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job DetailsThe individual conducts a compliant validation process for systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients and programmers/developers. Identifies current requirements and assures compliance according to the appropriate regulations which govern the user's applications. Keeps abreast of changing regulatory requirements and the availability of current techniques.This role is responsible to analyze, draft, design and execute validation strategies and develop protocols. Compile and analyze validation data, prepare reports and develop solutions for changes and/or improvements. Conduct or oversee validation testing in the field. Demonstrate commitment to the quality policy. Document work methods and procedures. Assist in the revision and enhancement of validation programs to accomplish corporate objectives. Identify, document and report defects according to procedure. Organize and maintain library of validation documentation, scripts and other files. Oversee validation tasks and resources that result in timely deployment of validation services within project timeline. Provide assistance to client during on site validation activities. Provide assistance to other team members as needed. Creates and executes validation planning for projects of moderate scope and complexity and revises as appropriate to meet changing needs and requirements. Remains abreast of developments in the field of manufacturing, computer technology, blood banking, quality and validation, as applicable. Schedule, plan and lead multiple projects, including the delivery of validation services and materials to clients and day to day oversight of validation cases. Track and communicate validation status to clients and management. Work closely with clients to measure the effectiveness of the validation programs. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in clinical laboratory science or equivalent or Science or Engineering Required 5-years of experience in validation and / or commissioningBlood Bank, Transfusion service and/or Donor Center experience is preferred KNOWLEDGE, SKILLS AND ABILITIES Knowledge of current industry practices and cGMP requirements related to validation tasks in a regulated environment. Technical writing skills Advanced demonstrated analytical skills Demonstrated written communication skills. Demonstrated customer service skills. Strong verbal communication and listening skills. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience... For full info follow application link. Haemonetics is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination against any applicant or employee based on any legally-recognized basis, including, but not limited to: race, color, religion, sex (including pregnancy, lactation, childbirth or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed service member status or any other status protected by federal, state or local law (Protected Characteristic). Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including managers and co-workers.