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 QA System Analyst 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.
Summary/Purpose:
The QA Systems Analyst ensures that the SAP system static data is updated per current specification/requirements and the EBR (POMSnet) system recipes are compliant to current specification/requirements. Follow appropriate policies, industry standards, government regulations, plant and departmental procedures to design, implement and maintain the systems. Provides state-of the-art knowledge to constantly improve the system and to create cost effective solutions to problems.
Responsibilities
Maintain integration of data requirements for quality systems (SAP, Thermo LIMS, MES, ERP, etc). Perform assessment and coordination for data management opportunities.
Perform system maintenance activities to ensure that it is updated to the current product specifications and requirements.
Create and maintain Inspection Plans synchronized within the applicable systems for raw material, commodities, and manufacturing products per approved specification.
Create and maintain master data for raw materials, commodities and manufacturing products (Master Recipes, Bill of Materials, etc.)
Monitor systems data interface for troubleshooting and correction of exceptions log events.
Provide support to Quality Control, SCM and manufacturing personnel on day today Electronic Batch Record (EBR) execution.
Create and maintain Product Master Recipes and Bill of Materials for manufacturing products.
Communicate with accounting, MES and Supply Chain group for recipe generation and updates.
Create Change Requests for changes in master data, inspection plans and master recipes.
As a Quality representative, may participate in the Change Review Board (CRB) and change control assessment process.
Request and/or approve as SME assessment of Impact forms for raw materials, commodities and manufacturing specifications for User Site Effective.
Qualifications
Educational requirements: Bachelor's degree in Science
- Minimum two (2) years of experience in Quality
- Experience in SAP is desirable
- Knowledgeable in LIMS system.
Fully Bilingual
Good interpersonal skills, teamwork, analytical and problem-solving skills. Experience in pharmaceutical manufacturing process is desirable.
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® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.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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