Position Title: Deviation Investigator Level 3
Work Location: Portsmouth, NH 03801
Assignment Duration: 06 months
Work Arrangement: Onsite

Position Summary: The Deviation Investigator Level III is responsible for the investigation and completion of deviations aimed at the identification of root cause and implementation of correct actions to prevent recurrence. Level III Investigators are expected to work in a cGMP environment, have working knowledge of mammalian manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Background & Context: Today, our organization is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Key Responsibilities:
• Share knowledge to significantly enhance performance within the organization with the long term view of constructing sustainable, high performing investigation teams.
• Draws from relevant experience to aid in real-time decisions for deviation containment and investigative response.
• Ability to manage moderate to high workloads with consistent on-time delivery.
• Ability to resume in-progress investigations with limited assistance from Sr. level investigators.
• Provide direction on deviation approach for the investigators and associated investigation teams, and as this occurs, transfer knowledge to the personnel involved to elevate expertise of the teams.
• Work to achieve >80% Right First Time on customer deviation reviews.
• Drive for effective CAPA such that deviations do not recur.
• Perform investigations for complex events with assistance from team leadership (as needed).
• Perform other duties as assigned.

Qualification & Experience:
• BS (or equivalent industry experience, 5-10 years) in Science Related Discipline.
• 5-10 years in cGMP Biopharmaceutical Industry (Advanced level).
• Complete understanding of the general and technical aspects of the job.
• Provides resolutions to a wide range of problems. Job requires judgement within defined policies and practices.
• Works with limited autonomy and under moderate direction. Routine work requires no direction. Work is evaluated upon completion to ensure objectives have been met.
• Agility, Business Acumen, Collaboration, Customer Focus, Driving Results, Leadership
• Ability to work inter-departmentally and with customers.
• High level of area specific operations and technical skills.
• Demonstrates Error Prevention System (EPS) behaviors – e.g. 3 way communication, questioning attitude, etc.
• Strong written and verbal communication skills.
• Utilizes multiple RCA tools including but not limited to Cause Mapping, Event and Casual Factor charting, and 5 Why.
• Demonstrate ability for effective Planning, Organizing and Controlling competency.
• Demonstrate sound decision making, considering broad scope of factors.

Working Conditions & Physical Demands (If Applicable): The demands described below are those essential functions that an employee must be able to accomplish in order to perform this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mental Demands: Significant challenge to lead investigations for Right First Time, On Time In Full Delivery. Will need proper balance between tactical and strategic delivery. This position requires individuals to combine innovation with the adherence to standardized procedures & compliance adherence. Substantially, the ability to perform within a dynamic and stressful environment in which the ultimate delivery of the organization exceeds expectations of matrixed stake holders.
Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 38.10/daily.