Job Description
Job Description
Quality Assurance Specialist
INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT 330. 397. 1302 TO SET UP A PHONE INTERVIEW!
Job Description
The Specialist Manufacturing is responsible for executing processes related to deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR/EN), and Change Control quality records. This role serves as the External Supply representative across functional teams to ensure the timely closure of quality records. The position manages quality records originating from manufacturing sites and acts as the main point of contact for the New Albany, OH site.
Responsibilities
- Address and close quality records such as Deviations, CAPAs, CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations, and Change Control under the company's quality management system procedures.
- Ensure compliance with regulatory agency requirements.
- Monitor and investigate deviations owned by External Supply and implement corrective/preventive actions.
- Partner cross-functionally to ensure the maturity and execution of robust Deviations/CAPA processes.
- Build and present quality records summaries for Senior Management review.
- Provide timely and comprehensive process and status updates to senior management.
- Collaborate with site and technical teams to evaluate observed supplier-related defects.
Essential Skills
- Quality assurance
- GMP
- Quality control
- Batch record management
- CAPA
- FDA compliance
- Audit
- Batch record review
- Strong communication
- Reliability
- Critical thinking
Additional Skills & Qualifications
- Master's or Bachelor's degree in a Science-related field preferred
- Experience with quality records, including CAPA and Change Control
- Familiarity with Veeva or TrackWise systems
- Prior experience in pharma, biotech, or medical device industries preferred
- Basic project management skills
- 3-5 years of hands-on experience managing deviations, change controls, and CAPAs
- Strong grasp of root cause analysis and investigation review
- Ability to operate in a fast-paced remote environment
- Associate degree holders with 10 years of deep experience will be considered
Work Environment
Work in a brand new, FDA/GMP-regulated facility that is very automated and high-tech. The environment is designed to support fast-paced and efficient work processes.
Job Type & Location
This is a Contract position based out of New Albany, Ohio.
Pay and Benefits
The pay range for this position is $28.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in New Albany,OH.
Application Deadline
This position is anticipated to close on Oct 23, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.