Responsible for tracking, management, and completion of Supply Chain Quality Records (such as deviations, material recalls, and CAPA) in partnership with applicable SMEs.
Leads error prevention and continuous improvement initiatives based on identified recurring root cause.
• Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for the Warehouse / Supply Chain team
• Responsible for all Level I key accountabilities:
o Responsible for the initiation, investigation and completion of Minor process deviations
o Demonstrates technical writing for the educated but uninformed reader, translate simple to moderate scientific events into a brief and cohesive report as a finished product
o Demonstrates ability to capture immediate actions and containment of the event, address comments from stakeholders on the compiled final report
o Displays ability to gather data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation
o Familiarity with cGMP quality systems, and demonstrates ability to read and comprehend GMP documents (i.e. SOPs, logs, Batch Records)
o Problem solving in a cross-functional setting, and participation and attendance at the deviation review board
o Management of multiple projects and timelines concurrently
o Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner
o Demonstrates professional interactions with internal team and with external customers to communicate investigational current status and comments resolution
o Communication of any escalations to team and upper management
o Demonstrates an openness to customer feedback, and takes action to enhance customer satisfaction within the scope of their role under guidance of supervisor/manager
o Generously shares information and knowledge with others across the team
o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, comments resolution.
o Works well on a team, and be able to trouble shoot and problem solve in a cross functional team setting
o Treats all co-workers and customers professionally and with respect
o Work on the Warehouse floor for data gathering and observing of processes for investigations
o Performs other duties as assigned.
Technical Knowledge
• Experience performing root-cause analysis, leading, and completing lab investigations
• Prior experience working in a laboratory setting required
• Responsible for intiation, investigation and completion of Minor/Track and Trend process deviations
• Demonstrates technical writing for the educated but uninformed reader, translate simple to moderate scientific events into a brief and cohesive report as a finished product
• Displays ability to gather data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation
Knowledge
• Familiarity with cGMP quality systems, and demonstrates ability to read and comprehend GMP documents (i.e. SOPs, logs, Batch Records)
Computer Skills
• Proficient in the use of spreadsheets, databases, and word processing software.
• Prior experience with TrackWise preferred
Decision Making
• Problem solving in a cross-functional setting, and participation and attendance at the deviation review board
• Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner.
Communication
• Writing is typically free of punctuation, spelling and grammatical errors
• Communication of any escalations to team and upper management. Provides timely, clear, and accurate updates without being prompted.
• Demonstrates professional interactions with internal team and with external customers to communicate investigational current status and comments resolution
• Generously shares information and knowledge with others across the team
Teamwork
• Dependable and able to work well within a team.
• Routine interaction with Quality Assurance and other Quality departments to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, comments resolution.
Initiative
• Actively attempts to understand the logic or basis for change in tasks or situations.
• Is optimistic and displays a positive attitude even during periods of adversity.
• Work on the lab floor for data gathering and observing of processes for investigations
• Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.
• Seeks feedback, reflects on their own development needs in order to improve continously
• Champions change speaking positively to and about others in all situations.
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