Deviation Investigator
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for a Deviation Investigator

Position type: Full-time Contract
Duration: 12 Months
Location: Bothell, WA 98021 (Onsite)

As a Deviation Investigator, you will:
• 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, 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 determine the associated corrective action to prevent the deviation from reoccurring.
• 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:
o Assess trend details to ensure accuracy and alignment across the team
o Facilitate in-depth root cause analysis to determine additional process and system failure modes
o Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
o 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:
o Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
o Seeks to understand, demonstrates humility, and shows curiosity for learning
o Completes deviations that are thorough, accurate, and complete
o Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase
o Understands appropriate assignment of classifications and requirements for each
o Understands the importance and impact of lot association within deviations and the relation to product disposition
o Captures the necessary data to support containment activities and impact assessment
o Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record
o Performs investigations and root cause analyses that are commensurate to the event being investigated
o Understands multiple RCA tools and when, where, and how to apply them
o Utilizes good technical writing skills
o Contacts vendor as needed to complete investigations in a timely manner
o May participate on deviation governance teams, projects, and other initiatives

Knowledge, Skills, and Abilities
• Expertise in GMP compliance and FDA/EMA regulations.
• 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.

Ideal candidate must have:
•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.

Vinay Bhatiya
Associate- Recruitment

PAY RANGE AND BENEFITS:
Pay Range*: $63.00 - $67.00 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws

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