Talentify
Quality Senior Specialist
This job is now closed
Job Description
- Req#: JP-005383461
- Lead and support investigations of unplanned events, ensuring timely evaluation, closure, and follow-up.
- Conduct root cause analyses and assess impact on Safety, Identity, Strength, Purity, and Quality (SISPQ).
- Define and manage CAPA timelines and ownership based on risk.
- Perform CAPA effectiveness checks for high-risk events.
- Chair Investigation Review Board meetings and oversee Trend Review Reporting.
- Act as the TrackWise SME and trainer, guiding others through the Investigation/CAPA process.
- Prepare and present quality metrics to leadership.
- Author, review, and approve SOPs to ensure procedural accuracy and compliance.
- 5+ years in GMP, Biotech, or FDA-regulated environments.
- 3–5 years of hands-on QA experience in pharma.
- Bachelor’s degree in a scientific or technical field (or equivalent experience).
- Strong knowledge of cGMP,FDA/EMA regulations, and quality systems.
- Proven project management and cross-functional collaboration skills.
- Excellent communication and documentation abilities.
- Proficiency in Microsoft Office; experience with TrackWise and SAP is a plus.
- Bonus: Experience in cell and gene therapy.
Make a Real Impact in Quality Assurance
Are you passionate about quality, compliance, and continuous improvement? Join a dynamic Quality Assurance team where your expertise will directly support the safety and integrity of life-changing therapies. As a Quality Senior Specialist, you’ll lead critical investigations, drive CAPA strategies, and ensure regulatory excellence in a fast-paced, collaborative environment.
What You’ll Do
What You Bring
Pay and Benefits
The pay range for this position is $93000.00 - $105000.00/yr.
35 shares
12.5 Bonus potential for each roleWorkplace Type
This is a fully onsite position in Columbus,OH.
Application Deadline
This position is anticipated to close on Jul 14, 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.
About the company
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
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