Job Details
The associate will ensure the needs of all interested parties are met. Those needs could include the timely and concise communication to internal and external functional groups about the project status and complications. The associate analyzes the performance of the distribution center team to achieve the final deliverable. If the analysis identifies challenges with the protocol, the associate uses that information to revise the protocol and apply lessons learned to new projects.
- Develop and evaluation of any client / regulatory related request for rework, relabeling, and shipping qualification for all 4 ICS Distribution Centers.
- Partner with client / regulatory agencies on needs and verifying ICS ability to meet expectations while ensuring compliance to all cGxP, cGDP, cGMP, and ISO/EU requirements.
- Strong ability to identify risk and establish contingencies to manage opportunity.
- Supports highly FDA regulated, high-priority medium scale projects that require high-levels of cross-functional integration.
- Develops and ensures completion of directives and projects from ICS’s clients into manageable and incremental work tasks that are executed by the ICS Distribution Center associates.
- Supports management of all documentation creation and reporting on current and future integration projects including periodic workstream reports and action items
- Create documents and other quality records to meet project, product, and process requirements.
- Coordinates with various work teams to ensure functional requirements are reflected in the final product.
- Supports the integration of new non-standard work requests into the quality and distribution management systems.
- Ensures project deliverables are accomplished within prescribed timelines
- Effectively manages simultaneous assignments.
- Good understanding of federal FDA regulations and ISO standards related to labeling, packaging, kitting, relabeling, repackaging, shipping studies, and work instruction protocol creation, storage, and accessibility.
- Work effectively with other project and quality team members.
- Perform effectiveness check of executed project to ensure specified business needs were met and requirements are fulfilled.
- Analyze processes and make recommendations for improvement and optimization, resulting in expense reduction, risk management strategies, and/or quality improvements in projects.
- Use results of effectiveness check to improve future and existing project outcomes
- Provides overall support to manage the development, monitoring, and trending of measurements to monitor progress.
- Support activities related to review and approvals of product dispositions and other inventory transactions from quarantine.
Experience and Educational Requirements:
- Currently pursuing a Bachelors degree
- Must not require sponsorship to work in the US now or in the future
- Technical understanding of cGxP, cGDP, cCMP, and ISO / EU requirements.
- Strong ability to identify risk and establish contingencies to manage opportunity.
Minimum Skills:
- Strong interpersonal skills required to develop and maintain cooperative working relationships interdepartmentally, with external customers and fellow associates.
- Strong analytical, conceptual, creative, and problem-solving skills to identify and resolve customer problems while focusing on ways to reduce errors.
- Critical, independent, and strategic thinking skills.
- Work independently to complete projects on time.
- Ability to deal calmly and effectively with situations while maintaining and promoting a positive image.
- Ability to organize, plan, and implement projects of various sizes.
- Ability to communicate effectively both orally and in writing.
- Ability to proficiently use a windows-based system and to accurately input data; preferably with intermediate Word, Excel and / or Teams skills.
- Ability to interface with computerized systems such as Salesforce, eQMS, SharePoint, and information portals.
