Validation & Compliance Specialist
Responsibilities:
Translate technical information and requirements into qualification/validation test design documents Sets work expectations with customers and delivers against them.
Familiar with software deployment and development life cycles.
Possess excellent customer consulting, written and communication skills.
Learn and understand the system processes and procedures of the Customer's Stand Alone or Enterprise Computerized system Document system and use processes and procedures for Customer review and approval Provisioning users on systems undergoing validation and document steps Track down root cause of errors during qualification and testing of systems undergoing validation activities and document solutions.
Assist with system configuration and changes as directed by Client Lead and document results/procedure to configure Perform and assist with planning and support activities associated with bringing new computerized systems on-board throughout the year and document configuration details Use BMRAM and DocCompliance for change control and project management as directed by Client Lead Generate validation documentation Additional
Responsibilities:
Audit response Validation Lab Administration PER requests Investigations Data backup configuration Software:
training and advanced end user Data integrity assessments Training Repair systems Technical SME SOP Authoring Implement continuous improvement Write change control requests and test plans Professionalism, excellent listening skills, superior analytical skills, great verbal and written communication skills Ability to manage one's time with minimal supervision to achieve objectives Basic
Qualifications:
Associate degree in Computer Science or Life Science AND 2
years of relevant technical experience including (but not limited to); Windows technologies, manufacturing systems, networking, technical writing Prior knowledge/education in GxP or similar type organization and Information technology disciplines within regulated industries.
Preferred
Qualifications:
Bachelor's degree in Computer Science or Life Science Experience with Technical Writing - Preferably Standard Operating Procedures or Technical Evaluation documents.
Experience with scientific/manufacturing instrumentation/equipment is a benefit Experience with file systems, software configurations, security, audit trails and tracing data flows within programs.
Experience with manufacturing environments and/or working in and with GMP regulated environments and systems Other Requirements:
Must be able to remains in a stationary position more than 25% of the time The person in this position needs to occasionally move inside and outside labs Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer Recommended Skills Active Listening Administration Analytical Assessments Auditing Biology Estimated Salary: $20 to $28 per hour based on qualifications.
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