
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 for Sr. Associate Quality Assurance to work in Juncos, PR. With us, it's all about finding the job that's just right
In support of Customer Quality Assurance program, we are seeking a highly motivated and talented staff to join us as Sr. Associate QA, to support and oversee the activities of the Plant Quality Assurance department in our inspection and packaging facility located in Juncos, Puerto Rico. A strong foundation in application of GMPs in a drug product manufacturing environment is critical, to quickly assess facts and make the appropriate decision when process/product quality may be impacted. The selected individual will perform sampling plans for all drug products, batch record review, audit the inspection and packaging process ensuring compliance to procedures and Quality standards as well as oversee aspects of QA operations within the facility, including but not limited to on-the-floor QA support, deviation investigations, change controls, and SOP revisions.
FUNCTIONS
- Perform sampling plans for all manufactured products.
- Perform batch record review.
- Perform SAP transactions.
- Perform Trackwise system queries, deviations.
- Participate in triage process.
- Perform oversight of the process and procedures/GMP tasks.
- Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies.
- Participate in internal plant audits.
- Work with operations to resolve basic compliance discrepancies.
- Assist in Investigations.
- May perform work of Associate QA.
EDUCATION
- Associate's + 2 years of Quality work experience OR?
- Bachelor's + 6 months of Quality work experience? OR
- Master's
Knowledge or experience with electronic batch record if possible and cGMP. In Process Quality Review/Aseptic Techniques Formulation/Syringe/Vial Manual inspection experience if possible.
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®
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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