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 QA 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.
Job Responsibilities:
· Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
· Able to approve MES exceptions related to production support worksheets and perform Quality Hold (as required).
· Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.
· Evaluate all deviations documented in batch records and determine the need for a corrective action.
· Track/trend batch record discrepancies per procedural requirements and work with other departments (e.g. Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.
· Review of the manufacturing process and related equipment and facilities to assure compliance with procedures, specifications, and policies.
· Give timely disposition to materials in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.
· Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product. · Enter required batch information into the lot restriction management system.
· Assemble the batch record review package and label per the approved retention procedures.
· Prepare reports including Right the First Time, Release Cycle Time and the delay reports.
· Generate lot lists for the Product Quality Review.
· Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release.
· Act as contact person for projects as required.
· Demonstrates accountability and responsibility of EHS performance and compliance.
Knowledge/ Education
· Bachelor's Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.
· Experience working in a Biotechnology Manufacturing Plant in areas of manufacturing, quality – 2 Years
· Experience in audit process
·. Knowledge in aseptic process
· Experience working in highly computerized Operations environments– 1 Year
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.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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