The purpose of this position is to serve as a primary investigator for the Operations Group to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions
This will be accomplished largely through leading and conducting appropriate root-cause analyses for events and authoring investigation reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products.
• 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.
• Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments.
• Exemplify the Renaissance Core Values of Integrity, Dignity, Perseverance and Trust.
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 . Bachelor’s degree in engineering or science field preferred. Experience with cGMP software such as Trackwise preferred.