Change Control - Project Management Associate

Project Management Associate – Change Controls

** Change Control person to take it through the entire process with SME’s

This PM Assistant will manage the "change control" process from start to finish working with the technical writing team and SME's.

Maintain trackers to manage change controls, initiating issues with change controls.

Responsibilities include ensuring adherence to agency regulations GMP and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with SME colleagues from our Manufacturing, Engineering, Validation, Supply Chain, Facilities, QA Ops & Systems, and other GMP supporting functions to ensure compliance to Good Documentation Practices (GDP).

Responsibilities:

• Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.
• Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator
• Review, edit, format master documents according to approved procedures and templates, maintains document properties (metadata), monitor document status and approval notifications, distributions and archiving
• Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks
• Issue effective documents including logbooks, procedures, test methods, specifications, batch documentation and labels and maintain issuance logs
• Execute duties associated with controlled document change requests (i.e., document formatting, approvals, effectiveness, and distribution)
• Assist with and provide on-going user support for electronic document management system
• Provide day-to-day operation support for departments (e.g. scheduling, reporting, records archiving)
• May also support the preparation and hosting of internal audits and regulatory (e.g. FDA, EMA, DHHS, etc.) inspections

Required Qualifications:

• B.S. degree and 2 years of experience in a related function, preferably in a pharmaceutical manufacturing facility
• Possess strong computer and Internet skills, including online document management experience and proficiency in Microsoft Office (Outlook, Excel, Word, & PowerPoint)
• Experience with Electronic Document Management Systems
• Excellent oral and written communication skills
• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with other

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.