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Validation Analyst
2 months ago
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 commissioning Blood 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 in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five
