Under the supervision of the Quality Systems Supervisor, the Lead Quality Systems Document Control Coordinator is responsible for driving departmental review of production documentation in a safe, quality and customer focused manner. This individual will act as an “on the floor” subject matter expert within our Quality Systems Document Management (QSDM) group to support the on time release of products following Good Manufacturing Practices.
We are seeking a self-motivated individual with strong communication, leadership and operational skills to lead the team’s daily activities of collecting, entering, disseminating and reviewing controlled documentation from various departments. This individual will coordinate these activities to ensure they are completed in an efficient manner and key customer expectations are met on time and in full. In addition to coordinating team activities, this individual will be responsible for conducting direct documentation review to support daily objectives.
Key Objectives of the role:
- Upholds departmental standards as required in a GMP environment
- Manages workflow of manufacturing batch records for optimum productivity
- Maintains schedule of rotating department tasks and assigns daily work assignments to team members
- Reviews manufacturing and customer facing documentation for accuracy to support timely release
- Processes final release of product according to quality control release standards
- Interacts with cross functional internal customers at all levels of the organization for resolution of issues
- Generates and presents detailed reports for continuous improvement metrics
- Provides feedback and coaching to team members on daily work tasks
- Multi-tasks efficiently in a high-paced environment
- Focuses on team objectives to meet customer expectations
- Supports training and cross-training efforts for team development
- Provides training for new hires and designates
Minimum Qualifications (must have):
- 3-5 years of work experience in a direct Manufacturing setting or combination of experience and education
- High School Diploma required
- Possesses effective communication skills both orally and written
- Excellent computer skills, display specific expertise in Excel
Preferred Qualifications (nice to have):
- Bachelors’ degree in Managerial or Business related studies
- Behaviors including: problem solving, professional demeanor, multi-task capabilities in high paced environment, motivational and team building skills, presentation and training skills, and delegation skills.
- Ability to work independently and in a group setting with little direction.