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 Associate Quality Analyst II 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.
General Position Summary/Purpose:
This is a new position/schedule. workers should be available to work on rotating shift every week due to 24/7 new business operation. final schedule still under revision.
During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the plant including performing Line Inspections, Quality Visual Inspections and Tub Hold management process. The incumbent supports the visual inspection certification process, resolution of deviations, participating in investigations, and assurance of compliance with cGMP and Customer policies for the manufacturing plant.
Key Accountabilities/Core Job Responsibilities:
• Responsible for performing the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and provide support for the Tub Hold Management process.
• Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.
• Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and regulations for the Quality areas under his/her responsibility.
• Support SVP Media Fill Program and QA Oversight execution activities.
• Place product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Revise standard operating procedures; ensures procedures comply with Customer policies and cGMP guidelines.
• Demonstrates accountability and responsibility of EHS performance and compliance
Additional requirements that we are looking for are:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• Prior experience in surveillance of aseptic filling process is a plus
Qualifications
Education: Bachelor degree in biotechnology/biopharma, biology, chemistry or engineering. Pharmaceutical experiences can be considered. Master degree is not needed. at least 1 year biotechnology/biopharma with aseptic processing experience is desired.
The combination of experience in one or more of the additional requirements listed below is a plus:
• Aseptic processing experience
• Quality Assurance experience
• Visual inspection of parenteral products experience – Principal activity.
• Participation and/or experience in Aseptic Process Simulation (Media Fills)
• Prior experience/certification in sterile gowning
• Prior experience in surveillance of aseptic filling process is a plus
What happens next
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 our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about, so let's get to work.
Kelly PR Offers!
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information, and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Bi-weekly pay
Among other benefits!
Apply Today!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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