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Job Description

This role is responsible for execution of the CAPA processes by owning the event occurrence, investigation, and documentation for any suspected policy, process, or procedure or production related system nonconformity. Responsibilities include:

• Leads the IT Compliance activities and strategy for specific CAPA (Corrective and Preventive Action) event evaluations, investigations, and resolution planning per established policies and procedures.

• Provides understanding and leadership of CAPA processes, System Life Cycle, BTS Quality System, validation and compliance processes/procedures to organization and stakeholders. Acts as a liaison and IT Compliance expert to assure successful investigations and corrective actions.

• Assembles and leads (virtual or onsite) CAPA CFT (cross-functional team) team with all needed parties/expertise to effectively and efficiently address assigned CAPA events.

• Exercises critical thinking to ask questions of discovery, confirm veracity of answers and locate information for CAPA record completion.

• Exercises Project management skills to drive for completion of CAPA events (assignment of action ownership, details, milestone dates) and ensures CAPA events are investigated and remediated according to schedule. Hold CFT members accountable for deliverables and create a sense of ownership and momentum to drive results.

• Monitor implementation plan and effectiveness check due dates and works with BTS IT owners to ensure implementations are completed on time.

• Applies technical writing and reasoning skills to author and/or approve documentation per policy and procedure to support CAPA activities. This includes evaluation, investigation, containment, resolution, implementation, and effectiveness checks in support of IT quality activities.

• Accountable for maintaining, reporting, and evolving the CAPA metric data for BTS, including developing management review metrics for upper management communications as needed.

• Escalates status, implementation, and effectiveness issues to CAPA management to communicate regular progress and mitigate quality system risk as needed.

Top Skills' Details

• Experience driving Corrective Action Preventative Action processes from event occurrence, investigation, documentation, and resolution.

• Strong understanding of IT systems in a quality environment

• Prior health care or life sciences experience

Additional Skills & Qualifications

Candidates should possess good organization, project management and documentation skills. The IT Quality Engineer will work with Systems SME's to compile information, create records and documentation to be reviewed by Auditors. Must have good critical thinking skills and able to synthesize information into a consumable story for an outside auditor to understand. Prior experience with ISO 13458, IEC 62304 would be a plus.

Employee Value Proposition (EVP)

This role will work with our client's Quality teams to review non-performance of their IT systems to ensure plans are created and put in place to avoid recurrence of issues. This will ensure events are investigated, findings documented, and issues resolved with external auditors.

Business Drivers/Customer Impact

The demand increase has resulted in a need to add an additional IT Quality Engineer to assist with their CAPA process. This process helps to investigate and resolve issues affecting our client's quality systems that may be impacted by IT systems. This role is crucial in helping avoid recurrence and maintain quality and regulatory standards.

Benefits Information

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision

• Critical Illness, Accident, and Hospital

• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

• Short and long-term disability

• Health Spending Account (HSA)

• Transportation benefits

• Employee Assistance Program

• Time Off/Leave (PTO, Vacation or Sick Leave)

  About TEKsystems:

We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.