My name is Phil and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Analytical Project Management Associate III for a prominent client of ours. This position is located in Research Triangle Park, NC. Details for the positions are as follows:
The Analytical Project Management Associate III is the Quality representative for Master drug substance (DS) and drug product (DP) Item Specifications and quality system document management of Master DS/DP Item Specifications.
· This position is responsible for creating and facilitating Master DS/DP Item Specification builds within the document management system. This requires a key understanding of GMP Guidelines, as well as a working knowledge of quality control methods, testing, and quality systems including documentation control.
· Assure specifications meet the expectations of company policies and GMP guidelines.
· Facilitate the execution of Master DS/DP Item Specification creation/revision/retirement and management of Master DS/DP Item Specification builds within the Quality Document Management System.
· Facilitate the execution of action plans and assist with change controls or other quality system activities associated with creation/revision/retirement of Master DS/DP Item Specifications.
· Assist with life cycle management of Master DS/DP Item Specifications within the Quality system, including periodic reviews.
· The Associate III should be able to work effectively within the group to promote robust teamwork and should have excellent written and verbal communication skills.
· Ability to communicate with management and peers globally across the organization.
· Excellent organizational skills, ability to multi-task and coordinate multiple activities in parallel.
· Working knowledge of cGMP and ICH guidelines as they apply to clinical and commercial testing.
· Basic understanding of biological and/ or chemical science principals.
· Experience with large molecules and/or small molecules, preferred.
If you are interested in hearing more about the position please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
About The Fountain Group:
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
The Fountain Group was founded in 2001 with the mission of providing quality resources to businesses on a contingent basis and has been providing quality individuals to National Fortune 100