Quality Engineering Specialist

Specific Responsibilities

• Identifying risk, developing mitigation strategies, alternative solutions, resolving issues, in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Supply Chain, Engineering and Validation.
• Supporting cGMP quality improvement efforts on-site and in remote facilities.
• Creating and maintaining company documentation, such as quality manuals, Standard Operating Procedures and Work Instructions.
• Applying good manufacturing practice and observing that it is being adhered
• Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
• Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.

Education and Qualifications

• BA/BS degree in scientific or engineering discipline
• 3+ years of bio pharmaceutical industry experience in a technical or supporting technical role
• 2+ years leading or supporting GxP System implementation and validation
• 2+ years of experience in a Quality role is highly desirable
• Demonstrable experience creating and utilizing inspection/testing
• Strong experience developing and executing protocols for single-use process systems, lab systems and software applications in a cGMP environment
• Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility
• Demonstrable experience utilizing risk-based assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.