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QA Investigator/Technical Writer
Actalent
Write and manage investigations, deviations, CAPAs in pharma manufacturing
9d ago
$40 - $45
Junior (1-3 years)
Full Time
Allendale, NJ
Office Full-Time
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
data analysis
capa management
root cause
investigation management
trend identification
quality assurance
- Analyze process data and evaluate trends to identify major improvement opportunities.
- Develop training materials to educate personnel on writing problem statements and using root cause analysis tools.
- Champion CAPA plans and implementation.
- Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates.
- Drive investigations to uncover true root causes using appropriate tools and benchmark industry standards.
- Determine the causes and preventative actions of Deviations, Non-Conformances, Out-of-Specification (OOS), Out-of-Trend (OOT), field complaints, and environmental excursion investigations.
- Collaborate with cross-functional teams to develop and track Corrective and Preventative Action (CAPA) plans.
- Oversee timely completion of deviations, CAPAs, and Change Controls.
- Define and implement effective preventative actions to prevent recurrence.
- Provide ongoing communication plans for deviations and CAPAs.
- Ensure adherence to quality standards.
- Identify and create appropriate trending rules that trigger corrective actions.
What you bring
bachelor's
technical writing
visio
excel
gmp
capa
- Bachelor's degree in a related scientific field.
- Experience in technical writing.
- Utilize change management approaches effectively.
- Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.
- 2-3 years of experience writing and reviewing deviations and investigations within a pharmaceutical company.
- Experience with GMP operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
- Experience with cell and gene therapies or biologics.
- Experience working with quality assurance teams to ensure accurate tracking and documentation of investigations.
- Proficiency in root cause analysis, CAPA, and biologics.
- Familiarity with e-Quality Management Systems.
- 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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Interview process
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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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