Deviation Investigator, Manufacturing

Investigations Manager

Own, lead, and support prompt, thorough, and well-written investigations assuring that root cause evaluations are performed in compliance with cGMPs and associated SOPs. Utilize technical writing strategies to ensure content is clear, concise, and complete. Drives investigations to timely closure through collaborative efforts with Operations, Quality Assurance, Engineering, and other functional areas, as needed. As needed, utilize investigational RCPS tools like 6M, Fishbone, and 5 Why’s to deliver thorough investigations.

Observe activities on the manufacturing floor and engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations. Work with the area owners to identify the most probable root cause(s) and determine appropriate preventive and corrective actions. Discuss investigations as required with regulatory agencies, quality assurance, or clients, as required. Utilize excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk.

Must be resourceful, self-reliant, self-motivated, and confident. Works independently and is flexible to changing priorities. Strong personal computer skills. Must have excellent teamwork and organizational skills.

Bachelor's degree in Science/Engineering with a minimum of 3 years of relevant experience in the pharmaceutical industry or additional education in project or documented investigational course work may be substituted for experience on a per year basis.

Experience with cGMP software such as Trackwise is preferred.