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Quality Specialist - Validation
Actalent
Develop, execute, and document cGMP validation for processes, systems, and equipment.
2d ago
$35 - $40
Junior (1-3 years)
Contractor
Durham, NC
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
What you would be doing
test cases
validation testing
data analysis
validation reporting
regulatory compliance
calibration tracking
- Communicate with Field Quality/Operations and other Operational and Quality Assurance personnel on compliance and cGMP issues.
- Ensure milestones and timelines are met for assigned projects.
- Write and execute test cases to validate critical control points, user requirements, and functional designs.
- Facilitate validation testing to ensure timely and documented approval before routine use.
- Provide feedback to Donor Center management regarding requirements and results from validation processes.
- Prepare validation summaries and reports for distribution.
- Analyze validation data to ensure acceptance criteria are met.
- Identify actions to add, remove, or revalidate processes, systems, and equipment.
- Evaluate the adequacy of corrective actions and participate in evaluating processes, systems, and equipment needs.
- Assist in the development of cGMP operating procedures related to process, computer systems, and equipment validation.
- Monitor and trend customer complaints and nonconformance related to equipment failures.
- Assure compliance with SOPs upon implementation and propose corrective actions as needed.
- Prepare validation equipment for use and evaluate upon return.
- Ensure validation approaches meet regulatory expectations and standards.
- Track and monitor process/system and equipment calibration failures/events.
What you bring
cgmp
fda
ms office
quality systems
analytical
problem solving
- Strong oral and written communication skills.
- Strong knowledge of current Good Manufacturing Practices (cGMPs) and standard operating procedures.
- Experience in developing and implementing quality systems.
- Excellent quantitative and analytical skills.
- Ability to identify errors and provide corrective actions.
- Knowledge of FDA and quality assurance/control documentation.
- Proficiency in Microsoft Office applications and computer applications used in the Donor Centers.
- Team collaboration skills.
- Critical thinking and problem-solving skills.
- Time Off/Leave (PTO, Vacation or Sick Leave)
- Health Spending Account (HSA)
- Employee Assistance Program
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Transportation benefits
- Critical Illness, Accident, and Hospital
- Medical, dental & vision
- Short and long-term disability
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
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Company
Overview
$1.3B Annual Revenue
Revenue Figure
Generated annually through a network of technical and consulting services.
27,500+ Consultants
Consultants Network
Comprises a global network of expert professionals across industries.
- Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner.
- Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services.
- Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects.
- Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems.
- Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.
- We empower people to realize their full potential by providing opportunities to grow and learn.
- We build lasting relationships based on trust, integrity, and respect.
- We champion innovation, continuously seeking creative solutions.
- We are committed to delivering exceptional results for our clients and employees.
- We foster a collaborative environment where team members contribute to collective success.
2050
Target Year
The company has set a goal to achieve net-zero emissions by the year 2050.
- focused on reducing its carbon footprint and enhancing environmental sustainability.
- committed to making energy-efficient investments and improving operational practices for sustainability.
- focuses on reducing waste and increasing recycling in its operations.
- This company prioritizes creating an inclusive workplace where diverse perspectives are valued.
- The organization strives to increase gender diversity and empower women at all levels.
- The company regularly monitors and tracks progress on gender-related diversity goals.
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