What are the responsibilities and job description for the Quality Engineer III position at Actalent?
Description:
This position works within the Quality Control department and is responsible for completing all aspects of deviation and OOS/OOT records originating from Quality Control.
Provide leadership by performing the following: cultivating relationships meeting their personal career goals while also achieving organizational goals building effective teams that apply their diverse skills and perspectives to achieve common goals driving engagement and creating a climate where staff are motivated to do their best.
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
Bachelor 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.
Skills:
investigations, CAPA, Root cause analysis, leadership, environmental monitoring, technical writing, GMP, OOT/OOS, RCA, quality assurance
Additional Skills & Qualifications:
Solid technical writing skills required.
Proven communication and interpersonal skills.
Facilitation skills for groups including staff level employees.
work in a fast paced environment with the ability to prioritize effectively to meet timelines.
drive functional technical and operational excellence as a result of investigation findings.
evaluate data and make recommendations based on data including trends and trend analysis.
Proactive approach towards continuous improvement opportunities
Experience Level:
Intermediate Level
About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
actalentaccommodation@actalentservices.com
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About the Company:
Actalent
