- Design Controls
- Communication Skills
- Quality Systems
Business Operations-Life Sciences/Pharmaceuticals
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
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