Job Details: Industry: Pharmaceutical Work Location: Fort Washington, PA Job Title: Document Control Specialist Duration: 8 Months (Temporary/Contract)
Document Control Specialist Fort Washington, PA Kelly Services is currently seeking a Document Control Specialist for one of our top clients in Fort Washington, PA. JOB DESCRIPTION:
The Document Control Specialist serves as the training Subject Matter Expert (SME) providing support of the day-to-day training operations. The GMP Training and Document Management Specialist supports Home Office and Network document control and training programs and initiatives. This role will assure SOPs and other GMP documents are created, routed, reviewed, assessed for training impact, approved, and made effective in compliance with departmental SOP's, company quality standards and current regulatory requirements.
The Document Control Specialist serves as the subject matter expert for the Electronic Document Management System. This role will assure SOP s and other GMP documents are created, routed, reviewed, assessed for training impact, approved and made effective in compliance with departmental SOP s, Quality Standards and current regulatory requirements. Areas supported by the GMP Training and Document Management Specialist include Home Office, Network (all product sites), External Manufacturing, as well as Home Office based functions such as Technical Operations, Regulatory Affairs, Marketing and Research and Development.
This position will support all aspects of the Records and Information Management Program, including managing all GMP records for retention to ensure records are indexed, secured and retrievable. Maintain all pertinent files and ensure records are retained in accordance with company policies.
Ensure quality and compliance in all my actions by:
o Maintain current training status for trainings designated for my role.
o Adhere to strict compliance with procedures applicable to my role.
o Exercise the highest level of integrity in the tasks that I perform.
o In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
o Embrace a behavior of employee involvement and commitment to doing the job right the first time.
The Document Control Specialist will:
o Process new or revised GMP documents in the document management system and assess the document for training impact.
o Serve as SME for assessing training needs, designing, developing and implementing GMP training programs including the creation and maintenance of training curricula.
o Partner with functional area managers and process owners to ensure personnel performing GMP roles have the knowledge, skills, and training to successfully execute their GMP responsibilities.
o Perform LMS transactions including user and item management, reports generation and maintenance of course content and completions as needed.
o Support LMS validation activities including test script execution as needed.
o Develop, coordinate and assist in delivery of new employee GMP orientation, Train-the-Trainer classes, and routine GMP training courses.
o Manage Training Materials Library and Training SharePoint (or equivalent) site.
o Author departmental SOPs and Supplements for GMP Training System.
o Design computer-based trainings to support the business needs of internal customers.
o Serve as Lead Investigator, CAPA Owner, and Change Control Author for HO GMP Training Department.
o Support needs of document control and training systems internal customers.
o Participate in audits and support inspection activities as directed by management.
o Conduct needs analysis, design and develop training strategies to develop personnel and increase effectiveness in present job assignment.
o Create and maintain curricula along with functional area manager.
o Process new or revised GMP documents in the document management system and assess the created, revised or obsolete documents for training impact.
o Partner with functional area managers and process owners to ensure personnel performing GMP roles have the knowledge, skills and training to successfully and compliantly execute their GMP Responsibilities.
o Ensure training and document control documentation is adequately maintained and managed according to procedures.
o Support LMS and the Document Management System validation activities, including test script execution as needed.
o Monitor functionality and communication between the Document Management System, LMS and related applications.
o Support needs of document control and training systems internal customers, including providing the Document Management System user training as needed.
o Oversee and manage the records and information management program.
o Support audits and inspection activities as directed by management.
o Create, run, and distribute related reports as needed.
o Create and maintain curricula along with functional area manager. Why Kelly?
As a Kelly Services employee, you will have access to numerous perks, including:
As a worker today, it s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what s next is what we re all about. We know what s going on in the evolving world of work just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
At Kelly, we re always thinking about what s next and advising job seekers on new ways of working to reach their full potential. In fact, we re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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