Deviation Investigator
Location: Ocean County, NJ
Pay: $70k - $75k
Position Overview
The Deviation Investigator will be responsible for leading and completing high-quality manufacturing investigations for the Operations Group. The role involves conducting thorough root-cause analyses and ensuring the timely implementation of corrective actions. The investigations will cover areas such as compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products.
Key Responsibilities
- Serve as the lead investigator for manufacturing deviations, ensuring investigations are completed on time and meet the required quality standards.
- Conduct root-cause analyses and draft comprehensive investigation reports, ensuring compliance with cGMPs and SOPs.
- Collaborate with cross-functional teams, including Operations, Quality Assurance, and Engineering, to drive investigations to timely closure.
- Use technical writing skills to produce clear, concise, and thorough investigation reports.
- Apply investigational tools such as 6M, Fishbone, and 5 Why’s to identify root causes effectively.
- Engage with Process Owners and observe manufacturing activities to gather relevant process knowledge.
- Collaborate with area owners to determine the most likely root cause(s) and implement appropriate corrective and preventive actions.
- Interface with regulatory agencies, quality assurance teams, or clients as required to discuss findings.
- Demonstrate excellent verbal and written communication, sound judgment, and strong analytical skills.
- Work independently with flexibility to adjust to changing priorities, while maintaining excellent teamwork and organizational skills.
- Support a collaborative and communicative environment across departments, fostering teamwork.
- Uphold the company's Core Values of Integrity, Dignity, Perseverance, and Trust.
Qualifications
- Bachelor's degree in Science or Engineering and a minimum of 3 years of relevant pharmaceutical industry experience.
- Additional education in project management or investigational course work may substitute for experience on a per-year basis.
- Experience with cGMP software such as Trackwise is preferred.
- Strong personal computer skills and proficiency in investigation tools and processes.
