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GxP IT Compliance Analyst

2 months ago

Waukegan, Illinois, United States Precise Solutions Full time


At Precise Solutions, we are on the lookout for exceptional consultants to join our team and support our clients across various sectors in the Life Sciences field.

We pride ourselves on being more than just a consulting agency; Precise Solutions offers competitive remuneration packages that include attractive salaries, comprehensive benefits, health insurance, paid time off, and employer-sponsored 401k contributions.


Position Overview:
GxP IT Compliance Analyst

Role Summary:
The GxP IT Compliance Analyst will play a pivotal role in overseeing quality supplier assignments. This position is essential in assisting with GxP IT Supplier Assessments, providing guidance, reviewing, and approving GxP IT suppliers to ensure adherence to established policies.
Key Responsibilities:
  • Generate, review, and offer insights on supplier documentation related to evaluations, remediation efforts, and periodic assessments.
  • Maintain supplier documentation within the audit management system and create unique identifiers.
  • Ensure identification and compliance of new GxP IT Suppliers with relevant policies and procedures.
  • Oversee issue resolution, collaborating with quality representatives until all matters are resolved.
  • Update and manage the Approved Supplier List for GxP IT Systems.
  • Conduct periodic GxP IT data extracts from relevant systems.
  • Ensure proper alignment of GxP IT Suppliers with various management systems.
  • Provide regular status updates, tracking progress until the completion of deliverables.
  • Offer GxP IT guidance to suppliers and system owners as necessary.
  • Assist in generating key performance metrics for suppliers.
  • Review supplier Standard Operating Procedures (SOPs) and related documentation for remote audits, producing Audit Summary Reports.

Qualifications:
  • Bachelor's Degree in Business, Information Technology, or Engineering.
  • 3-5 years of relevant experience in supplier evaluations or business projects.
  • Proficient in managing multiple projects with excellent communication skills.
  • Ability to learn quickly and adapt to changing circumstances.
  • Detail-oriented with strong organizational capabilities.

Preferred Skills:
  • Proficiency in Microsoft Office 365.
  • Experience in a quality-regulated environment, particularly with supplier evaluations.

Essential Skills:
  • Outstanding communication abilities.
  • Strong skills in Microsoft Office/Excel.
  • Detail-oriented mindset.
  • Excellent organizational skills.
  • Experience in a Quality, regulated environment.


We are committed to fostering a diverse and inclusive workplace where every team member can thrive.