Posting ID: JP-002276476
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., SOP’s, Work Instructions, Forms, Batch Records, WFP’s, WPP, Monographs) to ensure the functionality meets regulatory commitments.
b. 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.
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 Ensure the distribution and maintenance of historical records (e.g. superseded SOP’s, etc.) according to current Records Retention Policy.
2. Supports all the Operational areas by maintaining proper documentation according to current SOP’s. Ensure the compliance for the SOP’s 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 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 Ensure the distribution and maintenance of historical records (e.g. superseded SOP’s, etc.) according to current Records Retention Policy (paperback-up).
5. Assists and provides training to Manatí 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 CR’s of SOP, WI, WPP, BR’s, Forms or Technical Documents. Provide supplemented information related to all operation, periodic reviews, and documentation status reports (e.g., SOP’s, Work Instructions, Forms, Batch Records, WFP’s, WPP, Monographs) as per required not limited to quality meetings, audits, among others
Documentation, Pharmaceutical, SOP
Top Skills Details:
Additional Skills & Qualifications:
• 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
About Aston Carter:
At Aston Carter, we’re dedicated to expanding career opportunities for the skilled professionals who power our business. Our success is driven by the talented, motivated people who join our team across a range of positions – from recruiting, sales and delivery to corporate roles. As part of our team, employees have the opportunity for long-term career success, where hard work is rewarded and the potential for growth is limitless.
Established in 1997, Aston Carter is a leading staffing and consulting firm, providing high-caliber talent and premium services to more than 7,000 companies across North America. Spanning four continents and more than 200 offices, we extend our clients’ capabilities by seeking solvers and delivering solutions to address today’s workforce challenges. For organizations looking for innovative solutions shaped by critical-thinking professionals, visit AstonCarter.com. Aston Carter is a company within Allegis Group, a global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email firstname.lastname@example.org for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.
Recruiter: Jean Chambers
Phone: (410) 579-3072