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Deloitte IT Quality Project Associate in Boston, Massachusetts

IT Quality Project Associate

Business Operations-Life Sciences/Pharmaceuticals

Elkton, VA

We help clients align their people, process, and technologies with business objectives, and to improve and transform their operations and operational risk programs in a strategic and efficient way. In doing so, organizations can focus on what is important, anticipate risk, and enhance their overall operations to support their strategic objectives and bolster their risk preparedness. We are currently looking for Project Associates to performing a variety of IT Quality activities in pharmaceutical manufacturing plant setting. This is up to a 3 year assignment located in Elkton, Virginia and could eventually transition to Durham, North Carolina

Work you ll do

  • Author technical documents such as protocols, feasibility studies, and deviation investigations that align with corporate standards and industry requirements.

  • Adhere to Change Control procedures and ensure processes are maintained in a validated state through recertification / re-validation activities.

  • Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues.

  • Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on process or validation related activities/events.

  • Conduct equipment/system review

  • Participate as a quality system auditor

  • Development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates including test cases

  • Conduct risk assessments

  • Ensures that the system s validation state is maintained through proper testing as part of the change control program and re-validation as necessary. Performs a periodic review of systems to monitor the validation status of the system as well as an annual security audit. Executes validation role in validated system access process.

  • Assist with creation and maintenance of design history / technical file documentation


  • Comprehensive knowledge of quality systems regulations (ISO 13485, 21 CFR 820, 21CFR 210, 21 CFR 211), Knowledge of FDA Current Good Manufacturing Practices (cGMP), GAMP 5 requirements

  • Strong written and verbal communication skills

  • Strong interpersonal skills

  • Ability to independently develop and execute validation protocols

  • Experience with deviation and CAPA processes

  • Comprehensive knowledge of design control regulations

  • Knowledge of risk management regulations and processes

  • Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.

How you ll grow

At Deloitte, our professional development plan focuses on helping people at every level of their career to identify and use their strengths to do their best work every day. From entry-level employees to senior leaders, we believe there s always room to learn. We offer opportunities to help sharpen skills in addition to hands-on experience in the global, fast-changing business world


At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. at

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Category: Management Consulting

About Deloitte

As used in this document, Deloitte means Deloitte LLP and its subsidiaries. Please see for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.