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Quality Specialist II - Investigations
Actalent
22d ago
$28
Intermediate (4-7 years), Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Westerville, OH
Hybrid
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
quality review
sample management
process improvement
quality management
technical documentation
regulatory compliance
- Work under the close supervision of senior staff and leadership.
- Perform tasks according to established policies, procedures, and techniques, requiring training, common experience, or working knowledge.
- Reviewing escalations of quality concerns.
- Ensure all product samples are properly labeled and document all aspects of sample allocation and transition in the respective format and systems.
- Evaluate processes associated with sample management to identify gaps and implement improvements.
- Assist with all other quality documentation as needed.
- Maintain full accountability for product allocation across sample requirements and storage conditions.
- Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
- Document all activities performed according to GMP, cGMP, GLP, QC standards, clean room protocols, and technical writing guidelines.
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
- Complete, review, file, and archive documentation according to Standard Operating Procedures (SOPs).
- Perform some technical writing for investigations and CAPAs.
What you bring
bachelor's degree
regulated environment
collaborative team
clear communication
investigations
high productivity
- Must have experience in a highly regulated environment (GMP preferred, but would also be open to GLP, FDA, etc.)
- Must have a Bachelors Degree in a scientific field
- Function effectively in a diverse and collaborative team environment, utilizing clear communication to achieve high productivity.
- Must have experience writing investigations and/or CAPAs.
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Health Spending Account (HSA)
- Time Off/Leave (PTO, Vacation or Sick Leave)
- Short and long-term disability
- Transportation benefits
- Employee Assistance Program
- Medical, dental & vision
Information not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
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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