Must Haves:
- 3+ years of experience in a GMP/Pharma manufacturing environment
- Experience utilizing various investigation tools (5 Whys, Fishbone, 6 Ms, DMAIC method, etc.)
- Experience with technical writing (such as deviations, etc.)
- Ability to effectively organize data, extract key information, and write technical summary reports
Pluses:
- Scientific/Technical field of study preferred.
- Prior work experience in pharmaceutical or FDA regulated quality environment
- Pharmaceutical operations experience and/or knowledge
Job Description:
Insight Global is seeking an Investigator for a Pharmaceutical client in the Rocky Mount, NC area. This is an onsite role, that requires heavy technical writing. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. You will help us in investigation of our quality issues in manufacturing and quality laboratories. You will investigate deviations and out-of-specification results and atypical result investigations. Your problem solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.
Responsibilities:
- Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
- Ensure Quality Management System for the investigations department are followed and maintained.
- Conduct and write formal investigation reports with varying degrees of complexity with the assistance of plant personnel and oversight from Lead/Manager
- Frequently enters the production area wearing appropriate gowning as necessary, to collaborate with colleagues and gather information for each investigation.
- Prior investigation writing experience (with determination of product impact).
- Plans appropriate corrective action and preventative action (CAPA).
- Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
- Defining and recommending corrective and/or preventive actions identified through the investigation process.
- Facilitates strategy meetings.
