Description
Kelly® Science & Clinical is seeking Documentation Specialist for a 6 month contract position at a Global Pharmaceutical client in Manati, Puerto Rico. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Salary: $21.62 per/hour
Overview
This client is Global Biopharmaceutical companywhose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
In this role you'll be responsible for all the site documents, arrange the proper handling and filling for all documentation related to the manufacturing process through distribution of pharmaceutical products in a way that complies and ensures compliance with regulatory commitments, Federal and local regulations and site quality standards.
This role will give you an opportunity totransform patients' lives through science by contribute with a global leading biopharma company powered by talented individuals who drive scientific innovation.
Schedule: Office hours, but with the flexibility that we are working with projects and the hours can be extended.
Responsibilities:
Administers document workflow through electronic document management system to:
- Manage and coordinate document workflow through electronic document management system (DCA). Generate, reviews, proofreads and distributes official documents (e.g., SOP's, Work Instructions, Forms, Batch Records, WFP's, WPP, Monographs) to ensure the functionality meets regulatory commitments.
- Issue manufacturing operations official documentation (e.g., SOP's, Work Instructions, Forms, Batch Records, WFP's, WPP, Monographs) by preparing, revising and organizing controlled manufacturing documentation. Assure all Batch Records, WIQ, WPP, and forms were printed and documented correctly with the identification number that corresponds (by area, stage and product).
- Review DCA to ensure there is no duplication of documents at the time of reconciliation, and check that there are no errors in the system.
- Control Administers the assignment of new document numbers, document tracking, documents change request, and the tracking process of sign in/sign out of executed documents.
- Manage department archives: storage and retrieval of archived Regulatory Affairs documents in compliance with Federal and International regulations. Coordinate, review and prepare documents for secure storage retention.
- Keeps custody and / or advises of documentation to ensure availability, control & storage during and after inspections /audits activities.
- BS Degree with Two (2) years experience in a pharmaceutical industry manufacturing environment
- Knowledge of cGMPs, OSHA, local, International and Federal regulatory requirements, and documentation procedures
- Ability to audit documents from other areas and take corrective action as necessary
- Working knowledge of office equipment such as PCs (Words, Excel, and Power Point), copiers, shredders, and fax machines
- General knowledge of product manufacturing and packaging processes is a must
- Strong oral and written communication in English and Spanish is a must.
Once you apply, you'll proceed to 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 our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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 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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