Manufacturing Deviations Investigator
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Job Location:
Portsmouth, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview:
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients bioscience biopharmaceuticals custom manufacturing and cell and gene therapy the company provides comprehensive services across the pharmaceutical biotech and life sciences sectors. It supports every stage of drug development from early research to commercial production and offers solutions in biologics small molecules and specialty ingredients. Committed to quality and innovation the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes with a global presence that ensures access to scalable flexible and compliant technical expertise.
Job Title: Manufacturing Deviations Investigator
Location: Portsmouth NH - 03801
Duration: 7 Months
Job Type: Temporary Position
Work Type: Onsite
Summary
Deviation Investigator Level I III / Manufacturing Deviations Investigator is responsible for investigating and completing deviation cases to identify root causes and implement corrective and preventive actions (CAPA) to avoid recurrence. At higher levels (Level III) the role involves working in a cGMP environment with knowledge of mammalian manufacturing processes handling multiple projects simultaneously and demonstrating strong technical writing facilitation and compliance-oriented investigation practices.
The position also contributes to building sustainable high-performing investigation teams through knowledge sharing and continuous improvement.
Responsibilities
- Conduct deviation investigations and ensure timely completion.
- Identify root causes and implement effective CAPA to prevent recurrence.
- Make real-time decisions for deviation containment and investigative actions.
- Manage moderate to high workload with consistent on-time delivery.
- Resume and drive ongoing investigations with minimal supervision.
- Provide direction and guidance to investigation teams on deviation approach.
- Facilitate knowledge transfer to enhance team expertise.
- Achieve 80% Right First Time (RFT) on customer deviation reviews.
- Handle complex investigations with support from leadership when required.
- Perform additional duties as assigned.
- Experience working in a cGMP environment
- Knowledge of CAPA processes
- Strong technical writing skills
- Experience mentoring or guiding investigation teams
- Ability to manage multiple projects simultaneously
- Ability to build and sustain high-performing teams
- Strong decision-making in real-time scenarios
- Continuous improvement and knowledge-sharing mindset
- Strong investigation and root cause analysis skills
- Good meeting facilitation and conflict resolution abilities
- Ability to work independently with minimal supervision
- Strong time management and delivery focus
- Compliance-oriented mindset
- Knowledge of mammalian manufacturing processes
Key Skills
- Epidemiology
- Public Health
- Bank Secrecy Act
- Bioinformatics
- Fraud
- Genetics
- Interviewing
- Law Enforcement
- Qualitative Research Interviewing
- Research Experience
- Next Generation Sequencing
- Writing Skills
