Specialist QA
Juncos, PR, US
Scientific
Bachelors Degree
Full Time, Temporary
1xx
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Juncos, PR, US
1xx
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
| 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 Specialist QA to work with one of our top global biopharmaceutical clients in the Juncos, PR area. With us, it’s all about finding the job that’s just right FUNCTIONS - Review and approve product MPs. - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team. - Approve Environmental Characterization reports. - Release of sanitary utility systems. - Approve planned incidents. - Represent QA on NPI team. - Lead investigations. - Lead site audits. - Own site quality program procedures. - Designee for QA manager on local CCRB. - Review Risk Assessments. - Support Automation activities. - Support facilities and environmental programs. - Review and approve Work Orders. - Review and approve EMS/BMS alarms. - Approve NC investigations and CAPA records. - Approve change controls. - Provide lot disposition and authorize lots for shipment. Requirements -Masters + 2 years of directly related experience OR -Bachelors + 4 years of directly related experience OR -Preferred: Microbiology, Biology or Life Sciences |
| Knowledge in: • Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring • Sampling monitoring:? equipment and techniques • Data trending and evaluation • Microbiological testing methods and standards for clean rooms and controlled environments • Aseptic behavior in manufacturing areas to prevent contamination • Facility cleaning and disinfection • Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP • Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel) • Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data • Ability to analyze trend reports and environmental/CU data to identify areas for improvement • Hands on experience in electronic systems for instance: Documentation platforms such as Veeva, Spotfire, LIMS, Maximo. • Use of artificial intelligence tools such as data analytics and large language models • Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish. • Alerts senior management of quality, compliance, supply, and safety risks. • Supports internal/external audits and inspections as needed. |
10238713
I want more jobs like this in my inbox.
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.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.