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Description:

How will you make an impact? Assume site level responsibility for all major investigations including items originating from Production Quality Control Facilities etc. bull Coach and drive root cause analysis RCA bull Facilitate cross functional teams to evaluate causal factors. bull Provide written documented investigations per the site rubric in an appropriate and timely manner. bull Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues bull Work without direct guidance and minimal oversight to get results meet timelines and improve processes. bull Effectively communicate with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomes. bull Provide insights based on technical experience and astute judgment as called upon during investigations and daily interpretation of data and results. bull Perform work with little to no oversight. bull Perform technical writing of challenging investigations. bull Provide oversight for technically challenging investigations. bull Provide client communications and responses. bull Drive client communications and responses to closure through concurrences. bull Provide mentorship to deviation management team members. bull Lead the team in the absence of management. bull Assign the daily deviation workload in the absence of management. bull Attending Tier III for deviation updated when needed. bull Takes ownership of Tier I problem solving and daily accountability. bull Acts proactively to ensure streamlined process operations and promote team collaboration. bull Promotes a respectful and collaborative work environment. Education bull Bachelors degree in science required preferably in a scientific discipline. Experience bull Minimum of 5-7 years of experience in direct utilization of problem-solving tools RCA tools including 5-Whys TapRooT Fishbone/6M Kepnor-Tregoe Comparative Analysis etc. with demonstrated success. bull At least 7 years of experience working in a regulated environment preferably in biologics/pharmaceuticals. bull Preferred experience in either upstream or downstream processing. bull Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools. bull Minimum of 7 years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results. bull Demonstrated ability to perform intermediate to advanced levels of MS Office functions Word PowerPoint Excel. Equivalency: bull Equivalent combinations of education training and relevant work experience may be considered. Knowledge Skills Abilities bull Proficiency in technical and/or investigative writing. bull Excellent verbal and written communication skills. bull Ability to drive functional technical and operational excellence. bull Ability to evaluate data and make recommendations based on data analysis. bull Ability to make recommendations based on trends and trend analysis. bull Ability to work in a fast-paced environment with the capability to prioritize effectively to meet timelines. bull bull Facilitation skills for groups including staff level employees. bull Excellent time management and organizational skills to meet deliverables on tight deadlines. Preferred: TrackWise Root Cause Analysis TapRooT

Skills:

capa, root cause analysis, deviations

Top Skills Details:

capa,root cause analysis,deviations

Additional Skills & Qualifications:

CAPA, Deviation

About Actalent

Actalent 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 & Inclusion

At 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.

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