Job Abstract

IT Quality Assurance Analyst

Working in the regulated life sciences industry with GAMP5/21 CFR Part 11 and other global equivalent regulatory requirements, the Quality Assurance Analyst is responsible for supporting IT projects, service teams, and management in the quality aspects of implementation and maintenance of qualified/validated computer systems. In this role, the candidate will be responsible for participating in IT quality control activities such as,

• Testing plan development, risk assessments, evaluation testing, periodic reviews and execution for IT-related initiatives and activities
• development and completion of IQ/OQ documentation for IT-related initiative activities,
• Development of Policies and Procedures
• Interfacing with QA departments to clearly define the IT quality-related role and requirements in Projects, initiatives, and operational activities
• Facilitating periodic controls assurance activities, including but not limited to, periodic access reviews and system configuration and change management evidence collection

Candidates must have experience working within a team environment, partnering with other business, quality and IT teams from various global regions, possess analytical and problem-solving skills, and have strong communication skills.

Under the guidance of IT Management, duties and responsibilities will include:

• Exemplify the Sotera Health standard of Safeguarding Global Health.
• Provide quality assurance and testing support.
• Shared responsibility in creating and executing test scripts. - Validations
• Shared responsibility in creating IQ/OQ documentation - Validations
• Ensure all inquiries requiring follow-up work and/or calls are resolved.
• Facilitate periodic controls assurance activities – QA and Validations
• Liaise with QA to ensure alignment with the overall regulated company compliance obligations
• Liaise with system and platform SMEs – Does this include ALL systems? Or just the LIMs and LOMs (critical) What is the purpose of liaising with the system owners? Would this person be required to be in reviews of systems?
• Provide expertise and guidance in interpreting governmental regulations, standards, and agency guidelines to assess the impact on IT Infrastructure. of the business, legal, and regulatory environment for interpretation, and assess the impact on IT Infrastructure. (This seems unattainable to keep up to date on ALL regs, standards, and guidance. This is a huge ask for an Analyst with only 3 yrs experience).
• Support the development and maintenance of policies, processes, procedures, and other guidance documents that comprise the compliance framework.
• Escalate to QA for approval in accordance with company procedures, e.g.: Approval of key documents, required retention periods for technical records, and critical changes. (Would this person be owning the IT policies and control documents once they are in MC?) Whoever is the listed owner in MC will be responsible for revisions and reviews. Possibly also training sign-offs.
• Participate in projects as appropriate, based on risk, to provide quality guidance.
• Participate in process reviews and support continuous improvement.
• Perform internal quality and compliance assessments of IT processes Develop and maintain the assessment programs.
• Perform periodic assessments/reviews. (What does this comprise? Systems/Platforms/Infrastructure?)
• Conduct supplier audits (Is this IT specific? Or will this person be involved with QMS supplier audits with the Regulatory teams in each QMS?)
• Support audits of the IT Infrastructure, applications and services as required. (Would this person oversee IT audits? Whether on a global platform or within the individual business units?)

Required Skills and Experience:

• Degree in Computer Science or related field
• Minimum 3 years’ experience working with Quality Management Systems or highly regulated industries where GAMP5, 21 CFR Part 11, or similar quality standards are applied.
• Effective oral and written communication skills, as well as collaborative ability.
• Demonstrated critical, analytical, and troubleshooting skills.
• Proven ability to work independently or as part of a team.
• Effective time management skills, prioritization, and ability to meet deadlines.
• Strong interpersonal skills including the ability to communicate, influence, and work effectively with a wide range of people.
• Task ownership and ability to follow through to completion.
• Self-motivated, organized and detail-oriented.
• Flexibility to adapt to competing and/or changing demands.

Beneficial Skills and Experience

• Experience in developing and adhering to standard operating procedures.
• ALCOA+(+) Principles
• Electronic document management systems
• Demonstrated experience preparing for and/or participating in regulatory or customer quality audits.
• Experience in IT General Controls and Sarbanes Oxley regulations
• Project/Program Management Skills

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