PRIMARY DUTIES AND RESPONSIBILITIES:
- Provides support to Quality group ensuring consistent application of quality techniques
- Leads and manages key projects/initiatives related to Quality and ensures that progress is within expected guidelines and timelines.
- As the point of contact on assigned projects, performs a variety of highly skilled duties such as assembling, coordinating and managing multidisciplinary technical review teams.
- Provides technical and management advice and assistance to department management and personnel.
- Coordinates and manages day-to-day operations and communications with client and internal departments to ensure all elements are in spec and launch on schedule.
- Creates a detailed work plan which identifies and sequences the activities needed to successfully complete a project.
- Develops a schedule for project completion that effectively allocates the resources to the activities.
- Review the quality of work completed with the project team to ensure it meets project standards.
- Ensure that the project and work deliverables are on time, within budget and at the required level of quality.
- Identifies and determines quality improvement
- Establishes statistical confidence by identifying sample size and acceptable error
- Develops sampling plans by applying attributes
- Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
- Prepares reports by collecting, analyzing and summarizing data; makes recommendations
- Aids in maintaining Quality systems and other communication tools for Quality group
- Identify application opportunities for the technical/statistical tools of quality/process improvement
- Provide process improvement know how, methods and conceptual expertise to teams.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
- Education: Bachelor’s or equivalent work experience
- Experience: 5-8years of experience in Quality or Project Management related field
- Attention for detail and deadline driven
- Ability to work independently, multi-task and thrive in fast-paced environment
- A sense of urgency/initiative
- Superior organizational and leadership skills with ability to help team grow and thrive
- Demonstrate team building and problem solving skills
- Professional communication and presence
- Knowledge of cGMP requirements and ISO standards
- Ability to effectively prioritize and escalate issues
- Excellent implementation and customer service skills
- Product related knowledge and experience
- Experience in an analytical role
- 13485 Lead Auditor Certification or ASQ CQA