What are the responsibilities and job description for the Hiring: Deviation Investigator || Bothell, WA position at Sunrise Systems?
Job Title : Deviation Investigator
Duration : 12 Month Contract (Possible extension based on work performance)
Location : Bothell, WA
Hybrid Position
Job Description : Top Skills :
Minimum of Bachelor's degree in relevant Science or Engineering discipline and / or equivalent combination of work experience is required.
5 years of relevant cGMP experience. Experience in FDA / EMA regulation in the biotechnology and / or cellular therapy field is preferred.
Minimum of 2 years working within quality systems managing deviation and CAPA records.
Experience authoring deviation and CAPA records
This person will be a key player in the Jump MSAT team and a champion for quality priority principles and compliance within the Jump organization.
Minimum of Bachelor's degree in relevant Science or Engineering discipline and / or equivalent combination of work experience is required.
5 years of relevant cGMP experience. Experience in FDA / EMA regulation in the biotechnology and / or cellular therapy field is preferred.
Minimum of 2 years working within quality systems managing deviation and CAPA records.
Experience authoring deviation and CAPA records
Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.
Knowledge, Skills, and Abilities
Expertise in GMP compliance and FDA / EMA regulations.
Demonstrate excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Ability to anticipate and mitigate challenges.
Key Responsibilities
Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date
Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer / Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA
When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure
Owns and investigates department-specific trend deviations.
Leads investigation team to perform deep-dive analysis of department-specific trends, including to :
Assess trend details to ensure accuracy and alignment across the team
Facilitate in-depth root cause analysis to determine additional process and system failure modes
Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
Determine if previous identified CAPA are sufficient to reduce the trend by defined targets
Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations
Applies HOP (Human and Organizational Performance) principles to investigations
Uses both soft-skills and technical skills to drive the deviation and CAPA processes :
Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
Seeks to understand, demonstrates humility, and shows curiosity for learning
Completes deviations that are thorough, accurate, and complete
Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase
Understands appropriate assignment of classifications and requirements for each
Understands the importance and impact of lot association within deviations and the relation to product disposition
Captures the necessary data to support containment activities and impact assessment
Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record
Performs investigations and root cause analyses that are commensurate to the event being investigated
Understands multiple RCA tools and when, where, and how to apply them
Utilizes good technical writing skills
Contacts vendor as needed to complete investigations in a timely manner
May participate on deviation governance teams, projects, and other initiatives
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Hiring: Deviation Investigator || Bothell, WA?
Sign up to receive alerts about other jobs on the Hiring: Deviation Investigator || Bothell, WA career path by checking the boxes next to the positions that interest you.
Not the job you're looking for? Here are some other Hiring: Deviation Investigator || Bothell, WA jobs in the Bothell, WA area that may be a better fit.
We don't have any other Hiring: Deviation Investigator || Bothell, WA jobs in the Bothell, WA area right now.
