Jobs

Description

Must Have

• Basic statistical analysis skills for interpreting test data.
• Manufacturing Process Validation
• Process Failure Mode Effects Analysis (PFMEA)
• test method development / validation

Nice To Have

• Production transfer experience
• Product / process design

Job Description

• Responsible for supporting production line transfers, including creation of PFMEAs, leading component qualification activities, and test method development and validation.
• Ability to integrate into cross functional teams, and ability to find creative solutions to project quality needs, ensuring compliance to quality standards, and product needs. 
• Support launch and initial manufacturing operations and assure documentation and procedures are created, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.
• Conducts failure analysis, assists in the investigation of manufacturing issues during process development and provides data and input on technical issues and projects.
• BS or BA in chemical, biochemichal, mechanical, electrical or Industrial Engineering, Biological Sciences, Chemistry or other related field required with minimum 2 years of experience (project management experience preferred).
• Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
• Capable of using Microsoft programs and ability to learn other systems.
• Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills.
• The ability to work in teams and independently with minimal supervision to obtain results as required.
• Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.
• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).