QC/Deviation Investigator

Sunrise System Inc. is currently looking for

• The Deviation Investigator/Initiator Level II is responsible for the initiation, investigation and completion of Minor process deviations unassisted, and the supervised completion of Major process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI), and implementation of corrective actions to prevent recurrence.

• Technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product.
• Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
• Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, and Interviewing.
• Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner.
• Participation in the Daily Management meetings to update leadership or current deviation statuses.
• Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution.
• Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews.
• Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.
• Attendance throughout the daily management system and participation in the deviation review board.
• Perform other duties as assigned.

• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
• Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
• Ensure that all team members comply with safety rules and regulations.

• Strong organizational skills and record keeping with the ability to work overtime when needed.
• Ability to engage and interview co-workers to obtain relevant information pertaining to investigations.
• Strong attention to detail and organizational skills.
• Strong communication skills (written and oral).
• Independent and self-motivated.
• Familiarity with cGMP quality systems.
• Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, Power point).

• Bachelor’s (or diploma with relevant experience)