Deviation Investigator

Title: Deviation Investigator

Location: Portsmouth, NH – 03801

Duration: 6 Months

Job Description Summary:

• The Deviation Investigator Level III is responsible for the investigation and completion of deviations aimed at 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.
• Job Description*
• 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.

Education:

• BS (or equivalent industry experience, 5-10 years).

Work Experience :

• Area* cGMP Biopharmaceutical
• Industry Level* Advanced - 5-10 years

Skills

What analytical capabilities or niche skillset does this role require?

• 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

Competencies & Behaviors:

Agility*

Takes personal responsibility for promoting change in her/his area; challenges the status quo and looks for opportunities to make improvements in her/his area of the business and beyond

Business Acumen*

Uses knowledge of her/his own business area and related areas to identify and develop operational/financial improvements; sets and delivers on individual and team objectives that support the company strategy

Collaboration*

Actively seeks out and shares different perspectives from a broad network and implements alternative approaches; generously shares information and knowledge with others across teams and functions

Customer Focus*

Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate; manages internal and external customer relations professionally and effectively

Driving Results*

Ensures delivery excellence for own goals and those of her/his team; helps peers (and team) overcome performance obstacles and challenges

Leadership*

Takes personal accountability for outcomes resulting from choices and behaviors of self and team; takes personal accountability for defining and implementing her/his own development and supports others to do same