Computer Systems Compliance/Validation Specialist

Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium.  Our mission continues to focus on providing quality services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries.

Job Duties and Responsibilities

• Oversight and documentation compliance of electronic systems including archiving processes, including training for appropriate user groups.
• Complete SOP for clinical instrumentation qualification procedures, validation and work with Metrology and Validations Services (MVS) department on implementation.
• Audit all required SOPs for compliance to FDA and other computerized system guidance documents.
• Interface with quality assurance and laboratory operations as part of the Information Technology Group (IT) in structuring and implementing automated reporting templates to ISO and other standards.
• Complete review of standalone computer systems, process controls, passwords (per 21 CFR Part 11 requirements)  and keep information current for all departments.
• and assist with the implementation and validation of automation with vendors
• Create post validation help desk documentation-CAPA system-work with IT /QA to close out all open tickets
• Create training program for 21 CFR Part 11 methodology  and perform the training
• Assist QA and IT in all vendor and FDA/other audits related to computerized systems
• Participate in software system evaluations for regulatory compliance.
• Perform gap analysis on applications to address regulatory requirements such as Part 11.
• identify and document risk assessments.
• Take leadership role in all computerized system validations.
• Maintain compliance with master validation plan and keep MVP and other documentation current.
• Perform code review for any custom code applications.
• Assess and manage regulated from non-regulated business processes together with QA and IT

 Qualifications and Experience

• Associate’s or Bachelor’s degree in a technical or science field.
• 2-4  years’ experience working in regulated software systems.
• Attention to detail critical
• Strong interpersonal, writing, and communication skills.
• Proficiency in commonly used business applications.
• Working knowledge of SQL databases is a plus.
• Familiarity with statistical software is a plus.
• Knowledge of FDA 21 CFR Part 11 is a plus.

This is not a software QA position.

For additional information please visit our website at www.Toxikon.com.

Submit resumes to:

Human Resources

Toxikon Corporation

15 Wiggins Avenue

Bedford, MA  01730

Email:  hr@toxikon.com

 Toxikon employs 160 people and offers a generous benefit program including health, dental, fsa, std, ltd, life insurance and matching 401K plan. Toxikon is an EOE.