- 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
- 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.
- 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.
-
Deviation Investigator
Found in: Lensa US 4 C2 - 2 days ago
Axelon Bothell, United StatesPay range: $60 - $65/hr · Job Description: The 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 Juno Manufacturing Plant (Jump) located ...
-
Deviation Investigator
Found in: Lensa US 4 C2 - 2 days ago
Axelon Bothell, United StatesPay range: $60 - $65/hr on W2 · Job Description: The 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 Juno Manufacturing Plant (Jump) ...
-
Deviation Investigator
Found in: Lensa US 4 C2 - 2 days ago
LanceSoft Bothell, United StatesJob Title: Deviation InvestigatorLocation: Bothell, WA 98021Duration: 12 MonthsJob Description:The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management s ...
-
Deviation Investigator
Found in: Lensa US 4 C2 - 2 days ago
Integrated Resources Bothell, United StatesJob Title: Deviation Investigator · Location: Bothell, WA · Job Duration: 12 Months · Pay Rate: $63.86/Hr. on W2 · Job Description: · The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records th ...
-
Deviation Investigator
Found in: Appcast Linkedin GBL C2 - 2 days ago
LanceSoft, Inc. Bothell, United StatesJob Title: Deviation Investigator · Location: Bothell, WA 98021 · Duration: 12 Months · Job Description: · The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record ...
-
Deviation Investigator
Found in: Lensa US 4 C2 - 5 days ago
Pyramid Consulting Bothell, United StatesImmediate need for a talented Deviation Investigator. This is a 12+ Months Contract opportunity with long-term potential and is located in Bothell, WA (Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $53 - $63/ ...
-
Deviation Investigator
Found in: Lensa US 4 C2 - 5 days ago
LanceSoft Bothell, United StatesJob Title: Deviation Investigator · Location: th Ave. SE, Bothell, WA 98021 · Duration: 12 Months · Job Description:The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic qual ...
-
Deviation Investigator
Found in: Lensa US 4 C2 - 2 days ago
LanceSoft Bothell, United StatesJob Title: Deviation Investigator · Location: Bothell, WA 98021 · Duration: 12 Months · Job Description: · The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality rec ...
-
Specialist, Quality Assurance Deviation Investigator, Cell Therapy
Found in: MyJobHelper US C2 - 23 hours ago
PSG Global Solutions Bothell, United StatesAt Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of Investigator, Quality Assurance, Spe ...
-
Quality Investigator
Found in: Appcast US C2 - 3 days ago
Net2Source Inc. Bothell, United StatesPosition: Deviation Investigator · Location: Bothell, WA · Duration: 12 months+ Months (Extendable) Projected for 12 months and beyond depending on the business need. · This Position is onsite · Pay Rate: $63/hr on W2 Paid weekly (Without Benefits included in the pay you will ha ...
-
Quality Assurance Operations
Found in: Lensa US P 2 C2 - 3 hours ago
Omni Inclusive Bothell, United StatesJob Title: Senior Specialist, Quality Assurance · Location: Bothell, WA** 100% Onsite · *TOP SKILLS* · - 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system. · - Demonstrated ability to w ...
-
QA Shop Floor Specialist
Found in: Indeed US C2 - 4 days ago
Sunrise Systems, Inc Bothell, United States Contract*Job Title: QA Shop Floor Specialist* · *Location: Onsite role in Bothell, WA* · *Duration: 6 months (With possible extension )* · *Pay rate: $42/hour on W2* · *Position Type: Hourly contract Position (W2 only)* · *\*\*Schedule- 9:00pm - 7:30am, Sun - Wed\*\** · *\*\*Top Skills:* ...
-
QA Shop Floor Specialist
Found in: Appcast US C2 - 1 day ago
Pyramid Consulting, Inc Bothell, United StatesImmediate need for a talented QA Shop Floor Specialist. This is a 06+ Months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $35 - $42/h ...
-
QA Shop Floor Specialist
Found in: Appcast US C2 - 1 day ago
Aequor Bothell, United StatesPosition: QA Shop Floor Specialist · Location: Bothell WA 98021 · Duration: 6 months (possibility of extension for the right candidate depending on performance) · Pay rate: $42.41/ hour on W2 · **Schedule- 9:00 pm - 7:30 am, Sun-Wed** · **Top Skills: · 3-5 years of GMP work expe ...
-
QA Shop Floor Specialist in Bothell, WA
Found in: Appcast US C2 - 1 day ago
Rangam Bothell, United StatesPay Scale: $ $43.00 per Hourly · Job Description: · Schedule- 9:00pm - 7:30am, Sun - Wed · Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degree preferred, or HS Diploma + relevant work experie ...
-
Quality Assurance Specialist
Found in: Appcast US C2 - 1 day ago
Axelon Services Corporation Bothell, United StatesThis is W2 contract NO c2c/Corp to corp · Pay range: $40 to $44 per hour on W2 · Job Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degr ...
-
QA Shop floor Specialist
Found in: Appcast US C2 - 1 day ago
Sunrise Systems, Inc. Bothell, United StatesSunrise System Inc. is currently looking for QA Shop floor Specialist in Bothell, WA, Onsite with one of our top client. · Job Title: QA Shop floor Specialist · Location:Bothell, WA, Onsite · Duration: 6+ months · Position Type: Hourly contract Position (W2 only) · Job Descript ...
-
Quality Assurance Specialist
Found in: Appcast Linkedin GBL C2 - 1 day ago
Integrated Resources, Inc ( IRI ) Bothell, United StatesJob Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degree preferred, or HS Diploma + relevant work experience · Soft skills include- str ...
-
QA Shop Floor Specialist
Found in: Lensa US P 2 C2 - 3 hours ago
Aequor Technologies Bothell, United States**Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · ssociates or BA Degree preferred, or HS Diploma + relevant work experience · Soft skills include- strong cross-functi ...
-
QA Shop Floor Specialist
Found in: Lensa US 4 C2 - 12 hours ago
System One Holdings, LLC Bothell, United StatesJob Title: QA Shop Floor SpecialistLocation: Bothell, WAHours/Schedule: 9:00pm - 7:30am, Sun - WedCompensation: $ $42.41/hrType: Contract, Potential for extension or conversion to permanentResponsibilities Review executed batch records to ensure compliance with approved procedure ...
Deviation Investigator - Bothell, United States - System One Holdings, LLC
Description
Job Title: Deviation InvestigatorLocation: Bothell, WA
Compensation: $53.00- $63.86
Type: Contract
Overview
Leading biopharmaceutical company looking for an experience Deviation Investigator. Ideal candidates should have 5+ years of relevant GMP experience and at least 2 years of experience working within quality systems managing deviation and CAPA records.
Responsibilities
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
