Global IT Compliance Sr Specialist

Pennsylvania, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

A Bachelor's degree is preferred, but relevant work experience and education will be considered. A minimum of 5 years of experience in computer validation is required. Experience with quality records such as change controls, deviations, and CAPAs is necessary. Hands-on experience with electronic quality systems like TrackWise (QMS) and Documentum (EDMS) is also required. Expertise on Part 11 and Annex 11 forms and reports is needed.

Responsibilities

Ensure system compliance with applicable regulations throughout the software life cycle of development, implementation, and maintenance of automated systems involved in cGxP processes. Support IT system initiatives to provide defensible data integrity across GxP systems. Support all aspects of the company's Computer System Validation and global IT activities for systems supporting cGMP processes. Conduct quality reviews of Computer System Validation deliverables. Provide guidance related to data integrity initiatives and requirements for IT systems. Partner with IT team members for global GxP systems and support site & business unit IT compliance activities. Support internal and client audits and/or regulatory inspections. Provide expertise on Part 11 and Annex 11 forms and reports, including review/approval of regulatory impact system classification records. Work with CSV to provide timely periodic system reviews and audit trail reports. Attend project meetings to provide compliance direction and instructions to project teams. Assist with keeping the System Inventory List up to date and accurate. Create and provide guidance on CSV and Quality Related SOPs and Work Instructions.

Skills

IT Compliance

GxP

Quality Assurance

Software Lifecycle Development

Data Integrity

Regulatory Compliance

Automated Systems

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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