- Review records and documents, for completeness and compliance with QSR and ISO requirements.
- Review batch record to support release of raw materials, work in progress products.
- Generate standard operating procedures to define and improve quality system functions.
- Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
- Support the eDMS electronic documentation process as needed.
- Lead and participate in interdepartmental initiatives for continuous improvement.
- Provide companywide training on general quality principles and specific procedural requirements.
- Facilitate process improvement within other department, through the use of training, coaching, and team participation.
- Support the corrective action program, with hands on ownership for investigation and resolution of issues.
- Participate in the internal auditor program.
- Support QS Manager to implement and monitor Manufacturing and Quality Systems procedure
- Education and Experience (in years):
- High school degree (or equivalent experience) with 5 years of relevant work experience
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)
- Excellent verbal and written communication skills in group or one-on-one settings.
- Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems.
- Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
- Understanding of general mathematical principles and calculations, at college entry level.
- Experience in compiling data to support metrics analyzing current process.
- Understanding root cause analysis, failure analysis, six sigma and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting.
- Detailed and quality oriented.
- Strong organizational skills.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
PREFERRED QUALIFICATIONS (optional):
- Experience in DNA diagnostics or other medical devices
- Certified Quality Auditor or similar certification. (ASQ)
- Ability to work in an office environment
- Maintain flexibility in work schedule as interface with personnel on 2nd and 3rd shifts are sometimes required.
- Frequent walking between locations