Primary Responsibilities: Assist with project coordination and authoring of documentation for IT data integrity strengthening projects, including but not limited to: Acronis implementation and qualification for data backups and recovery. Manufacturing & QC Equipment software upgrades and/or implementation of additional software controls. Execution of audit trail and user access review processes. Implementation of secured USB access control process. Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes. Support GxP Change Management activities to ensure controlled qualification and deployment of IT system changes, record reviews, approvals, and completion of supporting documentation. Serve as SME on QMS records including change controls, continuous improvements, and CAPAs associated with computerized systems and data integrity. Authoring and lifecycle management of IT SOPs and Work Instructions. Qualifications: Bachelors Degree or equivalent certifications in Information Technology or a related field. 3+ years of pharmaceutical industry IT experience. Working knowledge of Computer System Validation (CSV), Data Integrity principles, and regulatory requirements for computerized systems, including 21 CFR Part 11 and EU Annex 11. Experience with Quality Systems such as Veeva for document authoring and Quality Management (Change Controls, Deviations, CAPAs). Strong attention to detail and a Quality mindset with commitment to accuracy and compliance. Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders. Project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively. Ability to work independently, prioritize competing activities, and maintain compliance under tight timelines. Relevant experience working with laboratory/manufacturing equipment such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV would be a plus. Relevant experience with instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, Hamilton, BacT with MYLA software, or other similar laboratory instruments would be a plus.
Project coordination, Analysis, Data analysis, Project management, Project coordinating
Project coordination,Analysis,Data analysis
w processes. Implementation of secured USB access control process. Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes. Support GxP Change Management activities to ensure controlled qualification and deployment of IT system changes, record reviews, approvals, and completion of supporting documentation. Serve as SME on QMS records including change controls, continuous improvements, and CAPAs associated with computerized systems and data integrity. Authoring and lifecycle management of IT SOPs and Work Instructions. Qualifications: Bachelors Degree or equivalent certifications in Information Technology or a related field. 3+ years of pharmaceutical industry IT experience. Working knowledge of Computer System Validation (CSV), Data Integrity principles, and regulatory requirements for computerized systems, including 21 CFR Part 11 and EU Annex 11. Experience with Quality Systems such as Veeva for document authoring and Quality Management (Change Controls, Deviations, CAPAs). Strong attention to detail and a Quality mindset with commitment to accuracy and compliance. Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders. Project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively. Ability to work independently, prioritize competing activities, and maintain compliance under tight timelines. Relevant experience working with laboratory/manufacturing equipment such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV would be a plus. Relevant experience with instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, Hamilton, BacT with MYLA software, or other similar laboratory instruments would be a plus.
Intermediate Level
This is a Contract position based out of Durham, NC.
The pay range for this position is $32.00 - $52.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
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)
This is a fully onsite position in Durham,NC.
This position is anticipated to close on Oct 9, 2026.
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.
Were a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. Were a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. Were strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. Were building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
We’re TEKsystems and TEKsystems Global Services. We accelerate business transformation for our customers, so they can capitalize on change and master the momentum of technology. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We’re building tomorrow by delivering business outcomes and making positive impacts in our global communities.
TEKsystems and TEKsystems Global Services are Allegis Group companies.
