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30 days old

Documentation Specialist

Kelly Services
Manatí, PR 00674
**Documentation Specialist**


PRINCIPAL OBJECTIVE OF POSITION


This position is responsible for the administration, maintenance and execution for all the documentation of Site Operations. Custodian 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.


MAJOR DUTIES AND RESPONSIBILITIES


1. Administers document workflow through electronic document management system to: a. Manage and coordinate document workflow through electronic document management system (DCA). Generate, reviews, proofreads and distributes official documents (e.g., SOPs, Work Instructions, Forms, Batch Records, WFPs, WPP, Monographs) to ensure the functionality meets regulatory commitments.


b. Issue manufacturing operations official documentation (e.g., SOPs, Work Instructions, Forms, Batch Records, WFPs, 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.


c. 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. d. 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. Serve as Subject Matter Expert on the use Record Retention program software, which maintains information regarding documents archived with Iron Mountain, and retrieve archived materials, as needed. Ensure the distribution and maintenance of historical records (e.g. superseded SOPs, etc.) according to current Records Retention Policy.


2. Supports all the Operational areas by maintaining proper documentation according to current SOPs. Ensure the compliance for the SOPs Periodic Reviews. Generate and evaluate report of Pending, Effective, Approved, Obsoleted documents to support management monthly presentations and managers, supervisors or employee requirements. Give follow up of Periodic Review documents to managers and supervisors, in order to ensure to comply with the regulatory commitment deadlines.


3. Provides compliance oversight and verifying compliance with company Policies, guidelines and regulations and verifies the area has consistency with other site procedures and/or specifications added to Purpose Lead or support changes in documents due to corrective actions or regulatory commitments.


4. Ensure the distribution and maintenance of historical records (e.g. superseded SOPs, etc.) according to current Records Retention Policy (paperback-up).


5. Assists and provides training to personnel in electronic document management system related issues and in the implementation of new initiatives.


6. Provide support during audits, investigations or any other activity that requires official copies of documents as requested (e.g. reference, documents, drafts, etc.). Keeps custody and / or advises of documentation to ensure availability, control & storage during and after inspections /audits activities. Support investigations providing supplemented information related to CRs of SOP, WI, WPP, BRs, Forms or Technical Documents. Provide supplemented information related to all operation, periodic reviews, and documentation status reports (e.g., SOPs, Work Instructions, Forms, Batch Records, WFPs, WPP, Monographs) as per required not limited to quality meetings, audits, among others.


Requirements:


Bachelor Degree

Two (2) years experience in a pharmaceutical industry manufacturing environment

Knowledge of cGMPs, OSHA, local, International and Federal regulatory requirements, and documentation procedures

Strong oral and written communication in English and Spanish is a must. 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

Ability to create complex forms using computer software packages (Microsoft Office) is a must


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-20 Expires: 2021-09-20

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Documentation Specialist

Kelly Services
Manatí, PR 00674

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