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QA Product Release Specialist
Jacksonville, FL, US
Scientific
High School or equivalent
Full Time, Temporary
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Jacksonville, FL, US
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Scientific
High School or equivalent
First Shift (Day)
Job details
QA Product Release Specialist
Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking for a QA Product Release Specialist for a long-term role at one of our Global medical device clients in Jacksonville, FL.
This role is a full-time, fully benefitted position. As a Kelly OCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly OCG employees receive annual performance reviews. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Shift: Monday through Friday (day shift)
Pay Rate: $26-28.00 an hour
Duration: one year likely to extend
This is role requires you bring your own laptop device
Responsibilities
- Ensures device history records are developed and completed in accordance with company and government regulations. Releases product from quarantine for clinical evaluation.
- Investigates and resolves discrepancies. Reviews and releases raw materials for use in clinical builds.
- Coordinates long term storage of files.
- Reviews and releases over labeling protocols for the over labeling of clinical product.
- Review forms and logbooks containing information that supports the release of clinical product.
- Work with personnel to keep Non-Conformance/Quality Event NC/QE investigations moving toward completion in alignment with closure metrics.
- Review and close Non-Conformances/Quality Events NCs/QE as assigned.
- Review test data supporting clinical release received from parameters, analytical, formulations, physical properties, etc. CAPA investigations: May involve being a member of the investigation team or owning the CAPA from the investigation phase through the action implementation phase.
Qualifications:
- High school diploma required.
- Application of principles, concepts, and practices of cGMP/GLP guidelines.
- Strong communication, organizational and interpersonal skills.
- Minimum 3 years of experience in Quality Assurance, Quality Control, or Quality Systems roles.
- Previous experience in product release preferred.
- Ability to identify issues and propose effective solutions.
- Experience in technical writing in relation to providing justification rationale and development of work instruction
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
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