For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
Provide quality assurance monitoring and audits of all Charles River computer validation projects globally to assure compliance with applicable regulations, corporate policies, and procedures. Assist in periodic assessments of globally controlled IT regulated activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Communicate all identified compliance and quality risks to his/her supervisor.
• Provide quality assurance monitoring of projects to assure regulatory compliance of complex and critical computer systems at designated sites, assisting with the development, review and/or approval of validation deliverables.
• Provide compliance support to Computer Validation QA managers on multisite and global computer systems, assisting with the development, review and/or approval of validation deliverables.
• Develop, review and approve global policies, standards and procedures.
• Assist in the development and maintenance of the computer validation training programs and present training in regulatory requirements for validation, maintenance, and operation of computer technologies.
• Assist with operational components, to develop and maintain an inventory of computerized systems used in regulated operations and their status relative to the Master Validation Process (MVP).
• Review and approve validation plans, test results, and summary reports for regulatory compliance. Prepare audit reports for validation projects describing regulatory and procedural deficiencies and deviations. Review audit responses and assure deficiencies are addressed before systems are commissioned for use.
• Work directly with the various staff and management on global internal audit-related activities including planning and oversight of IT internal audits, walkthroughs, testing, documentation of findings, issue remediation, follow-up, etc.
• Maintain an up-to-date knowledge of computer validation requirements, practices and procedures, and inform other company staff of those requirements.
• Provide compliance guidance to operational personnel on regulatory requirements for computerized system validation, development of user requirements specifications, testing strategies, and documentation requirements.
• Perform all other related duties as assigned.

Job Qualifications

• Education: Bachelor's degree (B.A./B.S.) or equivalent in a scientific discipline and/or computer related field.
• Experience: 5+ years related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of computer validation requirements in government regulations including FDA 21 CFR parts 11, 58, 211, and 820, OECDs, data integrity guidance and related multinational industry standards and requirements.
• 2+ years experience in auditing or quality assurance
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/License: None.
• Other: Must be able to communicate with essential personnel from all business sectors, i.e., manufacturing and research models services, clinical services, preclinical services. Demonstrated leadership skills required. Proficiency in computer-based word processing, spreadsheet and presentation applications required. Active membership of a professional organization specific to quality assurance and federal regulations (e.g. GLP, GMP, etc.)

PHYSICAL DEMANDS:

• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
• Must regularly communicate with employees/customers; must be able to exchange accurate information.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.

WORK ENVIRONMENT:

• General office working conditions; the noise level in the work environment is usually quiet.

Comments:

• Requires occasional domestic and international travel.

Job Type: Full-time

Pay: $70,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 5x8
• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• computer validation including FDA 21: 2 years (Required)

Language:

• English (Required)

Work Location: Remote

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