Quality Assurance Specialist

Job Description

Job Description

At Kelly® Science, Engineering, Technology & Telecom (SETT) , we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking an  Quality Assurance Specialist to work with one of our top global biopharmaceutical clients in the  Barceloneta PR area. With us, it’s all about finding the job that’s just right
Purpose:
The Quality Associate supports the Global Biologics Quality Function within Operations. Expectations that the Quality Associate III will maintain high-quality levels on all aspects of their job, while achieving high levels of efficiency.
Responsibilities:
• Responsible for various aspects of the product’s quality assurance related to their functional area.
• Ensures that product is consistently manufactured in conformance with Customer’s Quality System requirements and all applicable regulatory requirements throughout the network, including third party manufacturers.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with management for Quality Initiatives, Projects, Product Transfers, etc.
• Incumbent is responsible for ensuring compliance with Customer’s Quality Systems and cGMPs.
Qualifications
. Bachelor’s degree preferably in Engineering or Science & Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
2. Strong analytical skills and attention to detail and, strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
3. Knowledge of GMP regulations and standards affecting pharmaceutical products
4. Comprehensive knowledge and application of business and quality concepts
5. Change plan, Exception Reports, SAP and LRMS experience is highly preferred
6. Fully Bilingual English & Spanish
7. Candidate may work independently and have experience in Quality systems.

 

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