QC Engineer III

Responsibilities:

Assume site level responsibility for all investigations originating from Quality Control Laboratory and Stability group.

Perform root cause analysis (RCA)

Facilitate cross functional teams to evaluate causal factors

Provide a complete and thorough investigations in an appropriate and timely manner.

Ensure adequate CAPAs put in place have a holistic approach to reduce or eliminate recurrence of issues

Work with direct guidance and oversight to get results, meet timelines, and improve processes.

Provide effective updates to laboratory supervision and colleagues regarding status of investigations and recommendations based upon investigation outcomes.

Mentor colleagues by providing technical experience and judgment as called upon during investigations and proposed corrective actions.

Contribute to continual process improvement by participating in meetings, seminars, and site projects

Attend customer Face to Face/Virtual meetings, when appropriate, in support of investigation closure Solid technical writing skills required.

Proven communication and interpersonal skills.

Facilitation skills for groups including staff level employees.

Ability to work in a fast paced environment with the ability to prioritize effectively to meet timelines.

Ability to drive functional, technical, and operational excellence as a result of investigation findings

Ability to evaluate data and make recommendations based on data, including trends and trend analysis

Proactive approach towards continuous improvement opportunities

Equivalent combinations of education, training, and relevant work experience may be considered.

Requirements:

Bachelor's degree in science required, preferably in a scientific discipline.

Minimum of 5 years of experience in direct utilization of problem- solving tools with demonstrated success within a regulated environment

At least 4 years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.

Preferred prior experience in a Quality Control and/or Quality Assurance role with primary task of investigational work. Ideal experience would be both investigation and past people leader experience as this is a mentor role.

Exposure/Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools.