Quality Assurance representative on New Product Introduction Team. Responsible for the review and approval of workorders, risk assessments, validation protocols and reports. Perform Manufacturing Investigations, including RCA and CAPA development and implementation. Own site quality program procedures. Responsible for the development and management of Change Control. Provide lot disposition and authorize lots for shipment.

Doctorate degree or Master's degree and 3 years or Bachelor's degree and 5 years of experience or Associate's degree and 10 years of experience. The required experience must be in a similar role.

Competencies and Skills

- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.