IT Compliance Specialist / Data Integrity Specialist in North Chicago, IL

Hybrid (T-TH in office, possible M,F remote) 

Length of Contract: 1 year, potentially renewable

• Ensuring GMP compliance of archiving
• Support GMP systems
• Some one who understands GLP
• Will work on Software related projects on scientific side
• Some cloud deployment exp will be helpful
• IT and development sciences exp needed
• Documenting everything what they do
• IT background is a must have and will be needed for this role
• This is not a coding or a PM role
• Degree is nice to have
• Not looking for Python and C++ exp
• Basic IT computer science degree will work
• Bachelor’s degree in IT
• Not need someone who can run report or read report
• Some who can troubleshoot lab systems
• FDA MHRA or 3rd party inspection
• Team player who can identify issues related to IT compliance and business compliance
• Exp in lab and computer-based system in GLP and GMP arena
• Document requirements and business needs and future needs
• Provide day to day support in scientific lab including troubleshooting and
• OECD and MHRA regulations
• Someone who is open to learn new things
• Someone who understand data flow
• Someone who can work in lab
• Someone who can work in GXP or compliance role
• Not looking for a coder
• Some quality exp
• Associates degree will also work
• This is a more of a compliance role
• Someone who is an IT generalist
• Previous exp in regulated industry needed

Top skills

• Generic scientific knowledge is helpful
• ITIL certification or PM certification in Biopharma with IT background
• Bachelor’s degree with some understanding of
• Deployment of new systems
  

Job Responsibilities:

• Provides compliance support for GxP IT business systems within a R&D bio-pharmaceutical scientific organization
• Reviews, analyzes, and evaluates systems and user needs
• Documents requirements, supports scope and objectives in support of business strategies
• Manage laboratory instrument systems
• Work is managed via supervision of team lead and typically do not require exercising independent judgment
• Provide day-to-day support for laboratory scientific staff, including troubleshooting, system enhancements, training, etc.
• Work in a highly team-based, cross-functional environment for daily activities, decision-making, and project focus while exhibiting a “one-compliance” voice approach
• Identify and recommend practical solutions for improved business process efficiency
• Ability to manage several tasks simultaneously while ensuring all timelines are met
• Anticipate and respond to urgent and/or unexpected events and changing business needs with minimal impact on productivity
• Support Compliance/Business/QA partnership needs and initiatives for continuous improvement to enhance efficiency and compliance
• Provide input to regulatory and compliance requirements/expectations
• Identify and appropriately escalate potential compliance risks and/or issues as they arise
• Use sound and balanced judgment to discern the criticality of issues and act upon them accordingly

Qualifications:

Top skills/requirements/attributes for the candidate:

• Skill 1: In depth GxP Data Integrity understanding in a biopharma industry (at least 1 year experience)
• Skill 2: Efficient work planning, self-checking, execution, and accountability without requiring excessive direction and raises key questions when necessary.
• Skill 3: Proactive, transparent communication and collaboration with team leadership and other team members in a fast-paced team-oriented environment
• Skill 4: IT Project Management experience including a software validation.
• Skill 5: Understanding IT Lifecycle Management

Required years of experience, education, and/or certification:

• Bachelor’s Degree or equivalent certification(s) with technical business-oriented

Preferred (but not required) regarding skills, requirements, experience, education, or certification:

• Highly preferred: Laboratories Systems/software support, Direct experience with SNOW and or KNEAT as well as platforms, e.g.,), Microsoft365, and/or SharePoint applications

Preferred:

• PM Certification, ITIL Certification, familiarity with general scientific terminology, e.g., chemist, biologist, instrument, analytical testing, study, clinical, active ingredient, drug product

Work environment:

• Candidate will be an individual contributor within an R&D Scientific Compliance group that supports a broad variety of topics and processes. It is a modern hybrid work environment; comfortable, collaborative onsite work setting with professional equipment. At times candidate will have to perform work in a R&D scientific laboratory.

Other notable details about the environment from the hiring manager about this role

• Candidate will directly report to their supervisor for day-to-day guidance and assignment of work activities, with increasing individual worktime based on proven competency.

What positions/background experience do you feel are successful in this role

• Candidates with agile use of business communication skills, more advanced computer software systems administration\ support

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