15 Deviation Investigator Jobs in Bothell, WA
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SPECTRAFORCE is Hiring a Deviation Investigator Near Bothell, WA
Position: Deviation InvestigatorLocation: Bothell
Duration: 12 monthsThe MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Manufacturing Plant located in Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating No Impact, Minor, Major, and Critical deviations to determine root cause, and corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations, and determining the associated corrective action to prevent the deviation from reoccurring.
This person will be a key player in the MSAT team and a champion for quality priority principles and compliance within the organization.
A minimum of a Bachelor’s degree in a relevant Science or Engineering discipline and/or an equivalent combination of work experience is required.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Duration: 12 monthsThe MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Manufacturing Plant located in Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating No Impact, Minor, Major, and Critical deviations to determine root cause, and corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations, and determining the associated corrective action to prevent the deviation from reoccurring.
This person will be a key player in the MSAT team and a champion for quality priority principles and compliance within the organization.
A minimum of a Bachelor’s degree in a relevant Science or Engineering discipline and/or an 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 the selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, and personal and team accountability where it is critical to success.
- 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.
- 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 the definition and alignment of the investigation plan, required data, and timing for completion. Continues to partner with the investigation team throughout the investigation process to ensure agreement/alignment on the root cause and CAPA
- When CAPA is 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 previously 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
- Understand appropriate assignment of classifications and requirements for each
- Understand 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
- Understand multiple RCA tools and when, where, and how to apply them
- Utilizes good technical writing skills
- May participate in deviation governance teams, projects, and other initiatives About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Job Summary
JOB TYPE
Full Time
SALARY
$73k-101k (estimate)
POST DATE
05/18/2024
EXPIRATION DATE
10/03/2024
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